市場調查報告書
商品編碼
1468229
2024-2032 年按給藥途徑、適應症、配銷通路和地區分類的專業學名藥市場報告Specialty Generics Market Report by Route of Administration, Indication, Distribution channel, and Region 2024-2032 |
IMARC Group年全球特種學名藥市場規模達到 747 億美元。旨在利用能力、資源和市場影響力的策略合作數量不斷增加,線上藥局和遠距醫療平台的發展以及政府措施的增加是推動市場的一些主要因素。
特種學名藥是指高成本品牌特用藥物的學名藥。這些藥物用於治療複雜的慢性疾病,例如癌症、類風濕性關節炎、多發性硬化症和愛滋病毒。它們與傳統學名藥的不同之處在於,它們通常是基於生物製劑的,需要特殊處理和給藥(通常是注射劑),並且通常透過有限的網路進行分發。由於所涉及分子的複雜性質以及製造過程中使用的複雜工藝,特種學名藥的開發面臨獨特的挑戰。因此,與傳統學名藥相比,其核准監管途徑可能更加嚴格。此外,特種學名藥在醫療保健領域具有巨大的潛力。它們以較低的成本為患者提供重要的治療,同時也減輕了醫療保健系統的財務負擔。
線上藥局和遠距醫療平台等先進分銷管道的發展也推動了特種學名藥市場的成長。這些管道有助於輕鬆取得藥物,確保即使是偏遠地區的患者也能獲得所需的藥物。與此同時,政府醫療保健計劃和私人付款人也不斷尋求控制不斷上漲的醫療保健成本的策略。強調使用學名藥,特別是特種學名藥,是一個主要策略。因此,一些政府和保險公司現在鼓勵或強制規定學名藥的處方,從而推動需求。此外,價格較實惠的特種學名藥已成為該地區許多人的首選,確保更多人口能夠獲得基本治療。因此,這極大地支撐了市場。除此之外,針對更多利基和特殊條件的學名藥的生產正在為市場做出貢獻。此外,旨在利用合作實體的能力、資源和市場影響力的策略合作正在創造積極的市場前景。
對經濟實惠的醫療保健解決方案的需求不斷成長
隨著全球人口持續成長和非傳染性疾病 (NCD) 負擔的擴大,人們大力推動提供負擔得起的醫療保健解決方案。特種學名藥產業具有獨特的優勢來滿足這一需求。特種學名藥是品牌藥物的生物等效版本,為患者和醫療保健系統提供創新藥物的治療功效,但成本較低。此外,日本、美國和許多歐洲國家等已開發國家的人口老化導致慢性病發生率增加。這些疾病通常需要長期且複雜的治療方案,這可能會對個人和國家醫療保健系統造成經濟負擔。此外,在發展中國家,中產階級人口的擴張及其對先進醫療保健解決方案的需求給現有基礎設施帶來了壓力。
品牌藥物的專利到期
特種學名藥產業最重要的促進因素之一是品牌藥物專利的到期。當專利到期時,它為其他製造商生產和銷售這些藥物的學名藥打開了大門。鑑於學名藥的研發 (R&D) 成本通常低於新藥,因此這些藥物的價格可以更實惠,同時保持治療效果。每年都有年銷售額數十億美元的藥品失去專利保護。這為特種學名藥製造商提供了一個千載難逢的機會,可以進入擁有現成消費者基礎的成熟市場。因此,這些藥物的可及性將使更廣泛的人群受益,特別是中低收入家庭的人群,從而對市場產生積極影響。
藥物開發的技術進步
特種學名藥行業正在隨著更廣泛的製藥行業的發展而發展。同時,藥物開發和製造的最新技術進步使得更複雜的學名藥的生產成為可能,例如生物學名藥,而這在以前很難生產。此外,人工智慧和先進分析方法等工具簡化了這些藥物的研發 (R&D) 流程。這意味著專業學名藥製造商現在可以解決比以往更廣泛的疾病和疾病。此外,製造流程的創新確保這些藥物的生產品質穩定,並符合全球監管機構制定的嚴格標準。因此,它也為市場做出了貢獻。
The global specialty generics market size reached US$ 74.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 172.5 Billion by 2032, exhibiting a growth rate (CAGR) of 9.4% during 2024-2032. The rising number of strategic collaborations aiming to leverage the capabilities, resources, and market presence, the evolution of online pharmacies and telemedicine platforms and increasing government initiatives are some of the major factors propelling the market.
Specialty generics refer to generic versions of high-cost, brand-name specialty drugs. These medications are used to treat complex, chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis, and HIV. They differ from traditional generics in that they are typically biologic-based, require special handling and administration often injectables, and are often distributed through limited networks. The development of specialty generics presents unique challenges due to the intricate nature of the molecules involved and the complex processes used in their manufacturing. As a result, regulatory pathways for their approval can be more stringent compared to conventional generic drugs. In addition, specialty generics hold immense potential in healthcare. They offer patients access to vital treatments at a reduced cost, while also alleviating the financial burden on healthcare systems.
The evolution of advanced distribution channels, such as online pharmacies and telemedicine platforms, has also propelled the growth of the specialty generics market. These channels facilitate easy access to medications, ensuring patients in even remote locations can obtain the drugs they need. Along with this, government healthcare programs and private payers are continuously seeking strategies to contain escalating healthcare costs. Emphasizing the use of generic drugs, especially specialty generics, is a primary strategy. Therefore, several governments and insurance companies now incentivize or mandate the prescription of generics where available, thereby driving demand. In addition, specialty generics, being more affordably priced, have become the preferred choice for many in regions, ensuring essential treatments are within reach of larger segments of the population. Thus, this is significantly supporting the market. Apart from this, the production of generics for more niche, and specialized conditions is contributing to the market. Moreover, strategic collaborations aiming to leverage the capabilities, resources, and market presence of partnering entities are creating a positive market outlook.
Increasing Demand for Affordable Healthcare Solutions
As the global population continues to rise and the burden of non-communicable diseases (NCDs) expands, there's a significant push to provide affordable healthcare solutions. The specialty generics industry is uniquely poised to address this demand. Specialty generics, which are bioequivalent versions of brand-name drugs, offer patients and healthcare systems the therapeutic efficacy of innovative medicines but at a reduced cost. Additionally, aging populations in various developed countries, such as Japan, the United States, and numerous European nations, are leading to an increased incidence of chronic diseases. These conditions often require prolonged and complex treatment regimens, which can be financially taxing for both individuals and national healthcare systems. Furthermore, in developing nations, the expansion of middle-class populations and their demand for advanced healthcare solutions is putting a strain on existing infrastructures.
Patent Expirations of Branded Drugs
One of the most significant drivers of the specialty generics industry is the expiration of patents for branded drugs. When patents expire, it opens the door for other manufacturers to produce and market generic versions of those medications. Given that research and development (R&D) costs for generics are typically lower than for novel drugs, these medications can be priced more affordably while maintaining therapeutic efficacy. Each year, drugs with billions of dollars in annual sales lose patent protection. This presents a golden opportunity for specialty generic manufacturers to tap into established markets with a ready consumer base. Thus, the accessibility of these medications then benefits the wider population, especially those in low-to-middle-income households, positively influencing the market.
Technological Advancements in Drug Development
The specialty generics industry is evolving with the broader pharmaceutical sector. Along with this, recent technological advancements in drug development and manufacturing are enabling the production of more complex generics, such as biosimilars, which were previously challenging to produce. In addition, tools, such as artificial intelligence and advanced analytical methodologies have streamlined the research and development (R&D) process for these drugs. This means that specialty generic manufacturers now address a broader range of diseases and conditions than ever before. Furthermore, innovations in manufacturing processes are ensuring that these drugs are produced with consistent quality, meeting the rigorous standards set by global regulatory bodies. As a result, it is also contributing to the market.
IMARC Group provides an analysis of the key trends in each segment of the global specialty generics market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on route of administration, indication and distribution channel.
Injectables
Oral
Others
Injectable dominates the market
The report has provided a detailed breakup and analysis of the market based on the route of administration. This includes injectables, oral, and others. According to the report, injectable represented the largest segment.
The injectables route of administration has emerged as a significant market driver within the specialty generics industry. This growth can be attributed to the increasing prevalence of chronic diseases and complex medical conditions. Injectables offer advantages, including precise dosing and rapid onset of action, making them suitable for managing critical health conditions. In addition, the expiration of patents for certain branded biologics and specialty drugs has opened doors for generic manufacturers to enter the market with cost-effective alternatives. Moreover, the rising focus on research and development in the pharmaceutical sector has led to innovative injectable products with improved therapeutic outcomes. These market drivers collectively contribute to the growth and prominence of the injectables route of administration in the specialty generics industry.
On the contrary, the oral route of administration plays a pivotal role as a market driver within the specialty generics industry, due to the changing consumer preferences. Numerous patients prefer oral formulations due to ease of administration, eliminating the need for injections and reducing potential discomfort. Along with this, the vast array of chronic diseases and conditions requiring long-term treatment has contributed to the popularity of oral drugs.
Oncology
Autoimmune Diseases
Infectious Diseases
Others
Oncology dominates the market
A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes oncology, autoimmune diseases, infectious diseases, and others. According to the report, oncology represented the largest segment.
The rising prevalence of cancer continues to rise globally, necessitating a constant demand for effective and affordable oncology treatments. With an increasing number of patients requiring long-term therapies, the accessibility and cost-effectiveness of specialty generics become essential in improving cancer care. In addition, the expiration of patents for several branded oncology drugs has opened opportunities for generic manufacturers to enter the market, offering more affordable alternatives without compromising on quality. Apart from this, advancements in research and technology have led to the development of innovative formulations and drug delivery systems, enhancing the efficacy and patient compliance of oncology generics. Moreover, government initiatives and policies aimed at reducing the burden of cancer by promoting generic drug usage have further propelled market growth.
On the other hand, the infectious diseases route of administration has emerged as a crucial market driver within the specialty generics industry, influenced by the ongoing global burden of infectious diseases, including outbreaks and pandemics, has underscored the urgent need for effective and accessible treatment options.
Retail Pharmacies
Specialty Pharmacies
Hospital Pharmacies
Retail pharmacies dominates the market
The report has provided a detailed breakup and analysis of the market based on the distribution channel. This includes retail pharmacies, specialty pharmacies, and hospital pharmacies. According to the report, retail pharmacies represented the largest segment.
The retail pharmacies distribution channel plays a pivotal role as a market driver within the specialty generics industry, primarily influenced by the widespread presence of retail pharmacies ensuring convenient and accessible distribution of specialty generic medications to a broader patient base. As these pharmacies are typically located in various communities and neighborhoods, patients can easily access their prescribed medications without the need for specialized healthcare facilities. In addition, the rising prevalence of chronic diseases and the growing demand for long-term treatment options have amplified the significance of retail pharmacies in delivering specialty generics. Furthermore, the retail pharmacies' established relationships with healthcare providers allow for streamlined communication and collaboration, facilitating efficient prescription processing and patient care. As the demand for specialty generics continues to grow, retail pharmacies' essential role in distribution and patient support is set to reinforce the industry's expansion and accessibility to critical medications.
North America
United States
Canada
Europe
Italy
Germany
Spain
United Kingdom
France
Asia-Pacific
China
India
Japan
South Korea
Latin America
Brazil
Mexico
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest specialty generics market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (the United States and Canada); Europe (Italy, Germany, France, United Kingdom, and Spain); Asia Pacific (Japan, China, India, and South Korea); Latin America (Brazil, Mexico); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
The North America region is driven by the increasing prevalence of chronic diseases and complex medical conditions. It is leading to a growing demand for specialized treatment options. Specialty generics, with their cost-effective alternatives to branded specialty drugs, have gained traction in managing these conditions effectively. Additionally, the expiration of patents for certain branded specialty medications has created opportunities for generic manufacturers to enter the market, providing patients with more affordable treatment options. In addition, favorable government policies and initiatives aimed at promoting the use of generic medications have supported the expansion of the specialty generics industry in North America. These policies encourage generic drug usage, leading to enhanced patient access and overall cost savings in the healthcare system. Moreover, advancements in research and development leading to the introduction of innovative specialty generics with improved therapeutic outcomes are positively influencing the market.
The global specialty generics market is experiencing significant growth due to the escalating investments in research and development to develop innovative formulations, drug delivery systems, and combination therapies to improve the efficacy and patient compliance of their products. Ensuring compliance with regulatory standards and obtaining necessary approvals from health authorities in various countries is a critical aspect for specialty generic companies to launch and market their products. Along with this, the expansion of product portfolios to cover a wider range of therapeutic areas, such as oncology, immunology, and rare diseases, to cater to diverse patient needs is positively influencing the market. Apart from this, companies are offering patient support programs that provide counseling, adherence assistance, and financial aid to patients, thereby improving patient outcomes and medication adherence. Furthermore, collaborating with pharmaceutical companies, research institutions, and healthcare organizations allows specialty generics companies to access new technologies is contributing to the market.
Teva Pharmaceuticals Industries
Akorn, Inc.
Mylan N.V.
Mallinckrodt
Sandoz International GmbH
Pfizer, Inc.
Sun Pharmaceutical Industries Ltd.
Valeant Pharmaceuticals
Apotex Corp.
Endo International plc
In July 2023, Sandoz International GmbH declared intentions to establish a new technical development facility in Slovenia. Sandoz's Biopharma Technical Development skills will be significantly enhanced by the opening of a new end-to-end drug substance and drug product development centre.
In August 2022, Akorn, Inc. declared that a generic version of Cetrorelix Acetate for Injection, 0.25 mg (Cetrorelix) has been given FDA clearance. This is the first AP-Rated bioequivalent formulation of Cetrotide that has been authorized by Merck Serono.
In February 2022, Mallinckrodt issued a Complete Response Letter (CRL) in relation to the Company's New Drug Application (NDA) asking for approval of the investigational drug terlipressin to treat adults with hepatorenal syndrome (HRS), a severe and potentially fatal condition marked by a rapid decline in kidney function for which there is not yet an FDA-approved cure.