市場調查報告書
商品編碼
1494866
到 2030 年高活性藥物成分 (HPAPI) 市場預測:按產品、製造商、藥物類型、應用和地區分類的全球分析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 |
根據 Stratistics MRC 的數據,2024 年全球高活性藥物成分 (HPAPI) 市場規模為 345.1 億美元,預計在預測期內將以 11.7% 的複合年成長率成長,到 2030 年達到 670.2 億美元。
高活性藥物成分是一種在極低劑量下表現出生物活性的化合物。在人類基因組被描繪出來後,抗癌藥物開始為每個患者製造,而不僅僅是針對特定的癌症。全球高活性活性原料藥分為非專利藥HPAPI和創新HPAPI。非專利HPAPI 含有與曾經受化學專利保護的藥物相同的化學物質,而創新 HPAPI 則含有不同的化學分子。
據阿茲海默症協會稱,美國約有 620 萬名 65 歲及以上的人患有老年失智症失智症,預計到 2050 年這一數字將增至 1,270 萬人。
癌症發生率增加
HPAPI是一種高效的藥理活性成分。 HPAPI 的作用非常特異性,即使在較低的每日治療劑量下也具有很大的功效。 HPAPI 具有針對精確疾病細胞的能力,因此可用於配製高活性藥物。由於 HPAPI 的靶向釋放特性,它在標靶治療中得到了主要應用。在全球範圍內,癌症發生率正在顯著增加。癌症患者數量的增加對全球抗癌藥物的銷售產生了重大影響。
初始投資大
HPAPI 的細胞毒性帶來了重大的處理挑戰,並且需要大量投資來安裝特殊的防護設施以防止員工接觸。儘管 HPAPI 市場是一個新興且不斷成長的市場,但製藥商在升級現有設施方面面臨重大挑戰,這些設施只能處理具有低或中等藥理活性的原料藥。契約製造需要大量投資建設專用為 HPAPI 生產而設計的新設施,與常規 GMP 生產設施分開。
新興地區趨勢
印度、中國和中東等新興經濟體為 HPAPI 市場的參與企業提供了高成長機會。其中許多地區人口眾多、日益繁榮、壽命不斷延長,因此預計未來幾年市場將呈現高成長率。肌肉骨骼疾病、青光眼,尤其是癌症等疾病對全世界人民的健康狀況有重大影響,其中新興國家的成長率相對較高。
業界標準不斷演進
該市場參與企業(尤其是提供 HPAPI 製造服務的 CMO)面臨的主要挑戰之一是行業標準、技術和法規的不斷發展。想要進入這個市場的公司將需要採用這些新技術,這通常需要大量投資。例如,SAFC(美國)宣布,美國的 HPAPI 生產將採用更強大的分析技術,提高靈敏度和檢測水平,以確定十億分之一的潛在原料原料藥殘留,並且必須對設施進行升級。
COVID-19 大流行對高活性藥物成分 (HPAPI) 市場產生了重大影響。對有效治療方法和疫苗的需求激增,增加了包括 HPAPI 在內的製藥業的投資和產能。供應鏈中斷和關閉措施最初是一個挑戰,導致延誤和短缺。然而,這場危機加速了技術進步和監管核准,推動了 HPAPI 製造的創新和效率。
預計腫瘤學將成為預測期內最大的領域
由於癌症治療中含有大量 HPAPI,腫瘤學領域佔了最大的市場。癌症盛行率的上升是推動 HPAPI 需求的主要因素。此外,與荷爾蒙失調和青光眼等其他治療應用相比,對癌症的需求不斷成長以及標靶治療的最新趨勢是腫瘤學發展加快的關鍵因素。
預計合成材料領域在預測期內複合年成長率最高
合成 HPAPI 市場的成長速度很快,因為這些分子在非常低的劑量下就能非常有效地治療各種疾病。此外,許多合成分子預計將在未來幾年失去專利,從而促進市場成長。日本政府提倡使用學名藥來降低整體醫療費用和患者的經濟負擔。
由於先進的製藥基礎設施、嚴格的監管標準以及大量的研發投資,預計北美將在高活性藥物成分 (HPAPI) 市場中佔據最大的市場佔有率。該地區是大型製藥公司和受託製造廠商(CMO) 的所在地,進一步推動了市場成長。此外,慢性病盛行率的增加和對標靶癌症治療的需求增加了對 HPAPI 的需求,從而鞏固了北美在市場上的主導地位。
老年人口增加、慢性病和文明病盛行率高、可支配收入增加、文明病和老齡化疾病盛行率、政府醫療改革措施、推廣學名藥的採用 亞太地區預計複合年成長率最高。該地區製藥商的市場擴張得益於較低的人事費用和製造成本,這正在推動亞洲市場的成長。
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.