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市场调查报告书
商品编码
1372006
到 2030 年仿製药市场预测:按产品类型、给药途径、药物类别、适应症、应用、配销通路、最终用户和地区进行的全球分析Generic Drug Market Forecasts to 2030 - Global Analysis By Product Type (Super Generics, Biosimilar Generics and Simple Generic), Route of Administration, Drug Class, Indication, Application, Distribution Channel, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球仿製药市场规模为 3,968 亿美元,预计到 2030 年将达到 6,045 亿美元,预测期内复合年增长率为 6.2%。
仿製药是指在活性成分、剂型、规格、给药方法、品质、安全性、用途等方面与原厂药或新药在生物学上等效的药物。这些药物旨在具有与品牌药物相同的治疗效果,但通常以较低的价格出售。仿製药的主要目的之一是提供比品牌药更经济的处方笺替代品。仿製药有助于降低病患、保险公司和医疗保健系统的医疗费用。
根据IBEF 2021年11月发布的印度製药业报告,印度是全球最大的仿製药供应国。印度製药业供应美国40% 的仿製药需求和英国25% 的药品需求。
随着医疗保健成本的增加,成本控製成为人们更加关注的焦点。消费者、付款人和医疗保健专业人员越来越多地选择仿製药,因为它们通常比品牌药便宜。对平价药品的需求不断增加,这对仿製药业务有利。医疗保健行业的成长,例如住院和门诊就诊的增加以及处方药使用的增加,通常是医疗费用增加的结果。此外,仿製药的使用有可能显着降低医疗保健系统的成本,特别是公共资助的计划,例如医疗补助和医疗保险。这些计划允许您提供关键药物,同时透过选择仿製药来更好地管理您的财务,从而帮助推动市场成长。
限制仿製药成长的主要因素之一是 FDA 对评估仿製药中使用的准确性、副作用和其他成分的严格法规。如果製造商不遵守法规标准,药品经常会被召回。纯度、效价、稳定性和药物释放是影响仿製药性能的主要因素。为了达到所需的药物质量,必须将其法规在适当的限度、范围或分布内。要求批准仿製药的严格政府法规预计将阻碍市场开拓。
一旦品牌药的专利到期,仿製药製造商就可以开始生产和销售该药物的仿製品。市场竞争的加剧可能为客户和医疗保健系统节省成本。在仿製药的帮助下,患者可以以更实惠的价格接受重要的治疗。这对于买不起品牌药的人来说至关重要,而仿製药的供应可以扩大某些药物的市场。随着以前买不起品牌药物的患者开始寻求治疗,市场规模可能会扩大。
复杂的仿製药开发需要创建更复杂和困难的治疗方法的仿製药,包括生物製药和复杂的配方,这可能对仿製药行业产生许多有害影响。复杂的仿製药开发和核准,特别是生物仿製药(生物製药的仿製药),可能是一个耗时且资源密集的过程。这延迟了仿製药进入市场的时间,使患者在很长一段时间内没有负担得起的选择。由于证明与参考生物製药等效性和相似性的严格标准阻碍了市场成长,可能会出现法规障碍和延误。
与大型製药部门一样,仿製药行业也因封锁、旅行限制以及活性原料药和成品的製造问题而遭受供应链中断。国际贸易限制影响了仿製原料药的供应,因为许多活性药物成分是从中国和印度等国家获得的。由于大流行,对多种药品的需求增加,包括抗生素、COVID-19 治疗和抗病毒治疗。为了满足不断增长的医疗保健需求,仿製药製造商必须跟上不断增加的订单。
超级仿製药,也称为“增强仿製药”或“下一代仿製药”,是比传统仿製药更有效的最新仿製药。潜在的好处包括提高功效、安全性和便利性。开发超仿製药是为了减轻传统仿製药的缺点,同时实现合理的价格。与传统仿製药相比,超仿製药在提高疗效和安全性方面具有优势,这正在推动市场成长。
预计注射剂领域在预测期内的年复合成长率最高。这是因为注射剂是透过注射输送的,并且通常直接给药到循环系统或特定组织中。这些药物在医院、诊所和居家医疗等各种医疗机构中必不可少,用于治疗多种疾病。有多种药物作为通用注射药物出售,包括抗生素、止痛药、荷尔蒙和疫苗。感染疾病、慢性病和重症监护环境只是仿製药用于治疗和控制的一些问题。与名牌注射药物相比,可以显着节省成本,降低成本并改善获得医疗保健的机会。
在亚太地区,中国、印度等国的贡献最大。根据国际人口科学研究所(IIPS)的研究,截至2021年1月,估计约有7,500万60岁以上的人患有慢性疾病患者。心血管疾病、高血压和糖尿病影响全世界约 2000 万人。因此,印度慢性病盛行率的不断上升将增加对负担得起的治疗方法的需求,并推动市场的发展。由于上述原因,亚太地区预计成长更快。
欧洲的年复合成长率预计将在预测期内最高。这是由于人口高龄化、控制医疗保健系统成本以及品牌药物专利到期等原因造成的。在欧盟 (EU),仿製药的法规受到欧洲药品管理局 (EMA) 的强烈影响。仿製药要获得核准,必须满足严格的品质、安全性和功效要求。法律规范使仿製药成为品牌药物的安全有效的替代品。对生物相似药(生物製药的仿製药)的重视、非处方药 (OTC) 仿製药行业的增长以及数位健康技术对药物的影响是欧洲仿製药行业的显着发展。
According to Stratistics MRC, the Global Generic Drug Market is accounted for $396.8 billion in 2023 and is expected to reach $604.5 billion by 2030 growing at a CAGR of 6.2% during the forecast period. Generic medications are pharmaceuticals that, in terms of their active components, dosage form, strength, mode of administration, quality, safety, and intended use, are bioequivalent to name-brand or innovator medications. They are made to have the same therapeutic effect as the original brand-name medicine, but they are often marketed for less money. Offering more economical substitutes for name-brand prescriptions is one of the main goals of generic medications. They aid in lowering medical expenses for patients, insurers, and healthcare systems.
According to the Indian Pharmaceutical Industry Report published in November 2021 by IBEF, India is the world's top supplier of generic pharmaceuticals. The Indian pharmaceutical industry supplies 40% of the generic demand in the United States and 25% of all pharmaceuticals in the United Kingdom.
Cost containment is given more attention when healthcare expenses grow. For consumers, insurers, and healthcare professionals, generic medications are increasingly chosen since they are often less expensive than name-brand medications. The desire for affordable medicines has grown, which is good for the generic drug business. The growth of the healthcare industry, including more hospital admissions, outpatient visits, and prescription drug use, is frequently a result of growing healthcare costs. Moreover the usage of generic medications may significantly reduce the cost of healthcare systems, especially publicly financed programs like Medicaid and Medicare. These programs can supply vital pharmaceuticals while better controlling their finances by selecting generic substitutes thus propelling the growth of the market.
One of the key factors restricting the growth of generic medications is the strict restrictions, as the FDA evaluates the accuracy, adverse effects, and other ingredients used in generic pharmaceuticals. If the manufacturers don't adhere to regulatory criteria, pharmaceutical medications are frequently recalled. Purity, potency, stability, and drug release are the main factors that affect how well generic medications perform. To achieve the desired medication quality, they should be regulated within a suitable limit, range, or distribution. The tight government regulations that need clearance for generic medications are anticipated to obstruct market development.
When a brand-name medicine's patent runs out, generic drug producers can start creating and selling their copies of the drug. Due to increased market competition, customers and healthcare systems may be able to save money. Patients can acquire vital treatments more affordably with the help of generic pharmaceuticals. This is crucial for people who would not have been able to purchase the brand-name medication and the availability of generic treatments may increase the market for some pharmaceuticals. Patients who previously couldn't afford the name-brand medication may now seek therapy, expanding the market's total size
Complex generic development, which entails creating generic copies of more complex and difficult treatments including biologics and complex formulations, can have a number of detrimental implications on the generic drug industry. Complex generic drug development and approval, especially for biosimilars (generic analogues of biologic drugs), may be a time-consuming and resource-intensive procedure. This additional timeframe delays their arrival into the market, thereby depriving patients of affordable options for an extended period of time. Regulation barriers and delays may result from the demanding criteria for proving bioequivalence and resemblance to the reference biologic which impedes the growth of the market.
Due to lockdowns, travel restrictions, and issues with the manufacture of active pharmaceutical ingredients (APIs) and completed goods, the generic medicine sector, like the larger pharmaceutical industry, experienced supply chain disruptions. Restrictions on international commerce had an impact on the availability of generic medications because many APIs are obtained from nations like China and India. Demand for several medicines, including as antibiotics, COVID-19 treatment pharmaceuticals, and antiviral treatments, increased as a result of the pandemic. To address the expanding demand for healthcare, generic medicine makers have to react to growing orders.
The super generics segment is estimated to have a lucrative growth, because the super generics, sometimes known as "enhanced generics" or "next-generation generics," are a modern subset of generic medications that attempt to provide certain benefits above more conventional generics. Improved effectiveness, safety, and convenience are possible benefits. Super generics are created to alleviate some of the drawbacks of traditional generics while still being reasonably priced. When compared to conventional generic versions, super generics may have advantages in terms of improved therapeutic effectiveness and safety profiles which drives the market growth.
The injectable segment is anticipated to witness the highest CAGR growth during the forecast period, as these are provided through injection, often into the circulation or directly into particular tissues. These medications are essential in a variety of healthcare settings, such as hospitals, clinics, and home care and they are used to treat a wide spectrum of medical disorders. A wide variety of drugs, including antibiotics, analgesics, hormones, vaccinations, and more, are available as injectable generics. Infections, chronic illnesses, and critical care scenarios are just a few of the problems they are used to treat and control. When compared to name-brand injectable medications, they can provide considerable cost savings, lowering the cost and increasing accessibility to healthcare.
Asia Pacific is projected to hold the largest market share during the forecast period owing to rising medical knowledge among the populace and the region's aging demographic; In the Asia-Pacific area, countries like China and India contribute more than other countries do. A research by the International Institute for Population Sciences (IIPS) estimates that in January 2021, there were around 75 million chronically unwell Indians over the age of 60. Cardiovascular disease, hypertension, and diabetes affect roughly 20 million individuals worldwide. Thus, the increased incidence of chronic illnesses in the nation would increase the need for affordable therapies, propelling the market under study. As a result of the aforementioned reasons, the Asia-Pacific region is anticipated to have quicker growth.
Europe is projected to have the highest CAGR over the forecast period, owing to reasons including aging populations, healthcare systems' efforts to control costs, and the expiration of brand-name pharmaceuticals' patents. In the European Union, generic medicine regulation is heavily influenced by the European Medicines Agency (EMA). To be approved, generic medications must adhere to strict quality, safety, and effectiveness requirements. Generic medications are safe and effective substitutes for their brand-name equivalents thanks to the regulatory framework. The emphasis on biosimilars (generic copies of biologic pharmaceuticals), the growth of the over-the-counter (OTC) generic drug industry, and the influence of digital health technology on medication are a few prominent developments in the European generic drug business.
Some of the key players profiled in the Generic Drug Market include: Pfizer Inc., Sun Pharmaceutical Industries Ltd., Novartis AG, Mylan NV, Teva Pharmaceuticals Industries Ltd., Endo International plc, Lupin, Aurobindo Pharma, Hikma Pharmaceuticals PLC, STADA Arzneimittel AG, Eli Lilly and Company, Aspen Holdings, Fresenius SE & Co. KGaA., GlaxoSmithKline plc, Viatris Inc, Amneal Pharmaceuticals, Inc, Cipla Ltd, Abbott Laboratories, Sanofi, Baxter International Inc. and AbbVie Inc.
In October 2023, Pfizer presents new data at IDWeek 2023 Highlighting advances in prevention and treatment of certain respiratory illnesses and Other Infectious Diseases. Presentations showcase diversity and momentum of Pfizer's growing portfolio of vaccines and anti-infectives
In October 2023, Novartis presents new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer. Key data from the Phase III PSMAfore trial has been selected for a Presidential session.
In October 2023, Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment. Collaboration leverages the innovative R&D and commercial expertise of both companies.
In September 2023, Teva Presents Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above