![]() |
市场调查报告书
商品编码
1733636
2026 年至 2032 年品牌非专利市场(依药品类别、用途、给药途径、通路及地区划分)Branded Generics Market By Drug Class, Application, Route of Administration, Distribution Channel, & Region for 2026-2032 |
全球控制医疗成本的趋势日益增强,推动了品牌非专利市场的发展。随着全球医疗成本的上升,政府、保险公司和医疗保健提供者越来越多地转向品牌学名药。随着多种重磅药物的专利到期,学名药製造商将以低成本替代品进入市场,加剧竞争并降低价格,帮助市场在 2024 年增长至超过 2548.1 亿美元,到 2032 年达到 4030.7 亿美元。
此外,品牌学名药拥有良好的安全性、有效性和合规性记录,这增加了医疗保健专业人员和患者的信任,并加速了学名药的广泛采用。这些因素共同推动了品牌学名药的市场占有率不断增长。品牌学名药是一种满足可负担性和品质双重目标的医疗保健服务系统,预计从 2026 年到 2032 年,其复合年增长率将达到约 5.90%。
品牌非专利市场定义/概述
品牌学名药是使用公司品牌名称供应的专利到期药品,在成本效益和品牌可靠性之间实现了平衡。学名药广泛应用于心血管、糖尿病和呼吸系统护理等各个治疗领域,为品牌药提供了具有成本效益的替代品,同时保持了品牌药的品质和功效。随着对具有成本效益的医疗保健解决方案的需求不断增长、新兴市场医疗保健成本不断上升以及药品专利的不断到期,为製药公司扩大其品牌学名药组合创造了新的机会,品牌学名药的未来前景一片光明。
品牌非专利是以公司品牌名称供应的专利到期药品,在成本效益和品牌可靠性之间实现了平衡。学名药广泛应用于心血管、糖尿病和呼吸系统护理等各个治疗领域,为品牌药提供了具有成本效益的替代品,同时保持了品牌药的品质和功效。品牌学名药的前景一片光明。对具有成本效益的医疗保健解决方案的需求不断增加、新兴市场的医疗保健成本不断上升以及药品专利到期的不断到期,为製药公司扩大其品牌学名药组合提供了新的机会。
印度等国家就是此类措施的明显例子,政府推出了 PMBJP (Pradhan Mantri Bhartiya Janaushadhi Pariyojana) 等计画。该计划旨在透过名为 Janaushadhi Kendras 的专门零售店以合理的价格供应优质药品。此类项目不仅提高了学名药的可近性和可负担性,而且还促进了品牌学名药的市场渗透。政府可以透过让更多人获得品牌学名药学名药来增加其市场占有率。
在美国,药品价格竞争和专利期限恢復法案(即Hatch Waxman法案)的推出起到了关键作用。该法案为学名药的核准建立了框架,并包含解决品牌药和学名药製造商之间的专利纠纷的条款。这大大降低了学名药的市场准入门槛。这样的法律规范对于创造学名药能够蓬勃发展的竞争性市场环境至关重要。这样的法律规范有助于将创新需求与平价药品需求结合起来,从而促进品牌非专利市场的兴起。
此外,欧盟积极推动学名药的使用。欧盟的药品策略强调需要负担得起且可用的药品,并鼓励使用学名药来实现这一目标。例如,欧盟制定了法规,加快学名药的核准流程,并促进其在国家医疗保健系统中的使用。这些规定不仅将鼓励学名药的扩张,还将使品牌学名药获得更大的市场占有率。透过支持学名药,政府间接支持了品牌学名药学名药,该产业受益于人们对学名药的普遍接受度和信任度的提高。
政府不断推出推广学名药的倡议,推动了品牌学名药产业的发展。旨在降低医疗成本、改善药品取得管道和创造良好法规环境的措施非常重要。这些活动不仅促进了学名药的使用,而且为品牌仿製药创造了良好的市场环境,为品牌仿製药提供了成本更低但可靠的学名药替代品。随着各国政府继续推动平价医疗,品牌非专利市场预计将大幅扩张。
品牌非专利领域的扩张正面临日益增加的监管障碍的挑战。最大的监管障碍之一是将品牌非专利推向市场所需的复杂而漫长的核准过程。美国食品药物管理局(FDA)、欧洲药品管理局(EMA)以及其他国家卫生当局等监管机构对药品的安全性、有效性和品质保证制定了严格的标准。满足这些标准通常需要进行大量的实验室测试、记录并遵守良好生产规范 (GMP),这可能会导致产品延迟并增加製造商的成本。这种延误可能会妨碍品牌学名药的及时供应并减少市场竞争。
此外,不同地区不同的法律规范也造成了进一步的复杂性。每个国家可能都有自己的标准和核准流程,彼此之间可能存在很大差异。例如,学名药可能在某些地区快速核准,但在其他地区面临严格审查和延误。这种不一致迫使生产商必须遵循多个法律规范,这会耗费大量资源和时间。规模较小的组织尤其可能难以部署必要的资源来应对这些监管差异,这限制了它们在全球范围内有效竞争的能力。
此外,监管变化和升级可能会导致市场波动和不可预测性。政府和监管机构定期更新其政策,以跟上新的健康问题、技术突破和製药业的变化。虽然这些更新对于保护公众健康和安全很重要,但合规要求也可能迅速变更。製造商必须透过重新评估生产方法、进行额外测试和更新文件来不断适应这些变化。这些持续的调适要求可能会扰乱生产计划、增加营运成本并阻碍品牌学名药市场的扩张。
智慧财产权和专利诉讼是主要的监管障碍。品牌学名药製造商经常面临原产公司为保护其市场力量和智慧财产权而提出的法律挑战。专利问题可能导致昂贵且漫长的诉讼,从而推迟品牌非专利的推出并增加製造商的法律费用。此外,授予新药的监管独占权可能会在专利到期后继续有效,为原创公司提供额外的市场保护,但会推迟品牌非专利的到来。处理这些复杂的法律和监管问题需要大量的法律经验和财务资源,这对小型企业来说尤其沉重。
The increasing global trend of healthcare cost containment drive the branded generics market. As healthcare costs climb around the world, governments, insurers, and providers are increasingly turning to branded generics as a less expensive alternative to expensive branded pharmaceuticals. The patent expiration of several blockbuster pharmaceuticals has allowed generic manufacturers to enter the market with lower-cost alternatives, promoting competition and driving down prices propelling the market growth surpassing USD 254.81 Billion in 2024 and reaching USD 403.07 Billion by 2032.
Furthermore, the established track record of safety, efficacy, and regulatory compliance of branded generics is increasing trust among healthcare professionals and patients, hastening their uptake. These factors combined lead to the growing market share of branded generics, which meet the dual goals of affordability and quality in healthcare delivery systems globally growth is expected to grow at a CAGR of about 5.90% from 2026 to 2032.
Branded Generics Market: Definition/ Overview
Branded generics are off-patent pharmaceuticals supplied under a company's brand name, providing a balance of cost-effectiveness and brand dependability. They are widely utilized in a variety of therapeutic areas, including cardiovascular, diabetic, and respiratory therapies, and provide cost-effective alternatives to brand-name drugs while maintaining quality and efficacy. The future of branded generics looks promising, thanks to rising demand for cost-effective healthcare solutions, rising healthcare expenditure in emerging markets, and the ongoing expiration of drug patents, which creates new opportunities for pharmaceutical companies to expand their branded generics portfolios.
Branded generics are off-patent pharmaceuticals supplied under a company's brand name, providing a balance of cost-effectiveness and brand dependability. They are widely utilized in a variety of therapeutic areas, including cardiovascular, diabetic, and respiratory therapies, and provide cost-effective alternatives to brand-name drugs while maintaining quality and efficacy. The future of branded generics looks promising, thanks to rising demand for cost-effective healthcare solutions, rising healthcare expenditure in emerging markets, and the ongoing expiration of drug patents, which creates new opportunities for pharmaceutical companies to expand their branded generics portfolios.
Countries such as India provide a clear example of such measures, with the government launching schemes such as the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). This plan attempts to supply excellent medications at reasonable prices through dedicated retail stores called as Janaushadhi Kendras. Such programs not only increase the availability and affordability of generic drugs, but also promote branded generics' market penetration. Governments can help raise the market share of branded generics by making them more accessible to a bigger population.
In the United States, the introduction of the Drug Price Competition and Patent Term Restoration Act, sometimes known as the Hatch-Waxman Act, was critical. This Act established a framework for generic drug approval and included provisions to settle patent disputes between brand-name and generic manufacturers. It has greatly reduced the obstacles for generic medications to enter the market. Such regulatory frameworks are critical for creating a competitive market environment in which branded generics can flourish. They help to combine the demand for innovation with the need for cheap drug solutions, resulting in the rise of the branded generics market.
Furthermore, the European Union has actively promoted the use of generic medications. The EU's pharmaceutical strategy emphasizes the need of affordable and accessible medications, and it encourages the use of generics to accomplish this goal. For example, the EU has developed regulations to expedite the approval process for generic medications and promote their usage in national healthcare systems. These regulations not only promote the expansion of generic pharmaceuticals, but also allow branded generics to gain market share. Governments indirectly help the branded generics industry by supporting generics, which gain from improved acceptance and trust in generic medications in general.
Rising government measures to promote generic products are boosting the branded generics sector. Policies aiming at lowering healthcare costs, enhancing medicine access, and fostering a favorable regulatory environment are critical. These activities not only promote the use of generics, but also provide a favorable market climate for branded generics, which provide a low-cost yet dependable alternative to brand-name medications. As governments continue to promote affordable healthcare, the branded generics market is projected to expand significantly.
Rising regulatory obstacles provide a substantial challenge to the expansion of the branded generics sector. One of the biggest regulatory barriers is the complex and time-consuming approval processes required to bring branded generics to market. Regulatory entities such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities have strict criteria for pharmaceutical safety, efficacy, and quality assurance. Meeting these standards frequently necessitates considerable clinical testing, paperwork, and Good Manufacturing Practices (GMP) compliance, which can cause product delays and cost increases for manufacturers. These delays can impede the timely availability of branded generics, reducing their competitive edge in the market.
Furthermore, differences in regulatory frameworks among areas add an extra layer of complication. Each country may have its own set of criteria and approval processes that vary greatly from one another. For Instance, a branded generic may receive speedy approval in one region but face severe examination and delays in another. This inconsistency forces producers to traverse multiple regulatory frameworks, which can be resource-intensive and time-consuming. Smaller organizations, in particular, may struggle to deploy the resources required to manage these regulatory variances, thus limiting their capacity to compete effectively on a worldwide scale.
In addition, regulation changes and upgrades might lead to market instability and unpredictability. Governments and regulatory bodies routinely revise their policies to accommodate new health concerns, technological breakthroughs, and changes in the pharmaceutical industry. While these updates are critical for safeguarding public health and safety, they can also result in rapid changes in compliance requirements. Manufacturers must constantly adjust to these changes, which may include reevaluating their manufacturing methods, undertaking additional testing, and updating documentation. This ongoing requirement for adaption can interrupt manufacturing timelines and raise operating costs, impeding the expansion of the branded generics market.
Intellectual property rights and patent litigation create considerable regulatory impediments. Branded generics producers frequently face legal challenges from originator businesses looking to safeguard their market dominance and intellectual property. Patent issues can result in costly and extended litigation, delaying the release of branded generics and increasing manufacturers' legal fees. Furthermore, regulatory exclusivities given to new pharmaceuticals may last beyond patent expiration, offering further market protection to originator businesses while delaying the arrival of branded generics. Navigating these legal and regulatory intricacies necessitates significant legal experience and financial resources, which can be especially taxing for small and medium-sized businesses.
The increasing demand for antihypertensive medications is expected to greatly enhance the branded generics market. High blood pressure, sometimes known as hypertension, is a common chronic illness that affects millions of people worldwide. It is a major risk factor for cardiovascular disease, stroke, and other health consequences, thus proper care is critical. As hypertension awareness grows and healthcare systems work to reduce the burden of chronic diseases, there is a greater demand for low-cost treatment choices such as branded generics.
Branded generics provide a compelling value proposition by offering pharmaceuticals that are bioequivalent to their branded equivalents yet less expensive. This economic issue is essential in areas where healthcare budgets are limited or where individuals may pay a considerable amount of their prescription expenditures out of pocket. Branded generics are quality-assured alternatives to brand-name antihypertensive pharmaceuticals, allowing for more access to important prescriptions and increasing treatment adherence and outcomes.
Furthermore, the aging population, as well as the increasing prevalence of lifestyle-related risk factors such as obesity and sedentary lifestyles, contribute to the rise in hypertension. These demographic and lifestyle trends continue to drive up demand for antihypertensive drugs among a wide range of patient populations. Branded generics producers are reacting to this need by broadening their product portfolios to include a wide range of antihypertensive medications, increasing market penetration and satisfying the different needs of healthcare professionals and patients.
Furthermore, regulatory assistance and actions encouraging generic medications contribute to the expansion of the branded generics market for antihypertensive treatments. Governments and healthcare authorities throughout the world are increasingly recognizing the value of generics in lowering healthcare costs and enhancing access to important medicines. Policies that encourage generic substitution and speed approval processes for generic pharmaceuticals contribute to a competitive market in which branded generics can thrive. These regulatory frameworks provide an enabling climate for businesses to invest in the development and production of high-quality branded generic antihypertensive medicines.
The hormones area in the branded generics market is expanding rapidly due to a number of causes. Diabetes, thyroid diseases, and menopausal troubles are among the most common hormonal disorders worldwide. As knowledge and diagnostic capabilities improve, more people are being diagnosed with these illnesses, which increases demand for hormone replacement medicines and other treatments. Furthermore, advances in medical research and technology have resulted in the creation of novel and improved hormone therapies, accelerating market expansion. The aging population, combined with lifestyle changes and environmental variables, is driving up the demand for effective hormone therapy.
The increasing demand for oral route formulations is expected to drive significant growth in the branded generics industry. Oral drugs are the most prevalent and favored method of drug delivery due to its comfort, ease of administration, and familiarity with both healthcare providers and patients. This preference applies to a wide range of therapeutic areas, including chronic disorders like hypertension, diabetes, and cardiovascular problems, as well as acute infections that require pain relief or antibiotic therapy.
This desire stems from the increasing worldwide burden of chronic diseases. Long-term management of conditions such as hypertension and diabetes necessitates the use of trustworthy and cost-effective treatments. Branded generics provide a tempting alternative by offering pharmaceuticals that are bioequivalent to their brand-name equivalents yet less expensive. This affordability is critical in areas with low healthcare budgets or where patients pay a major amount of their prescription costs out of pocket, increasing access and adherence to treatment.
Additionally, advances in pharmaceutical formulation technology continue to spur innovation in oral drugs. These improvements improve drug delivery systems, increase bioavailability, and reduce dose frequency, resulting in better patient compliance and treatment outcomes. For example, extended-release formulations allow for less frequent administration, which improves patient comfort and may improve therapeutic efficacy. Pharmaceutical companies are investing in the development of novel oral formulations that suit specific patient needs, such as pediatric formulations or those designed for senior populations, hence increasing the market potential for branded generics.
Furthermore, governmental assistance and actions encouraging generic drugs play an important role in driving market growth. Governments and healthcare authorities around the world are progressively promoting the use of generics to decrease healthcare costs and enhance access to important medicines. Policies that simplify the approval process for generic pharmaceuticals and encourage generic substitution create an atmosphere in which branded generics producers can enter and compete in the market. These regulatory frameworks contribute to patients' access to safe, effective, and inexpensive oral pharmaceuticals, hence promoting worldwide branded generics market growth.
Topical administration is the second fastest-growing segment of the branded generics industry. Topical drugs are administered directly to the skin or mucous membranes, providing targeted treatment with less systemic side effects than oral medications. This approach is especially popular for dermatological disorders like eczema, psoriasis, and acne, because direct treatment to afflicted regions delivers specific therapeutic advantages. Topical formulations are also rapidly being used in pain treatment, wound care, and cosmetic dermatology, which is supporting their widespread adoption and market expansion.
Country/Region-wise
In North America, the pharmaceutical environment is shifting significantly toward cost-effective therapies, which is projected to drive the expansion of the branded generics market. Branded generics are drugs that are bioequivalent to branded counterparts but are sold under a different trade name. This category has grown in popularity since it is less expensive than original branded pharmaceuticals, making it a more appealing option for healthcare providers, insurers, and patients.
The increase of branded generics in North America reflects the growing effort to keep healthcare prices low. With healthcare spending on the rise, both governments and private insurers are looking for ways to cut costs while maintaining treatment efficacy and safety. Branded generics provide a tempting alternative because they strike a compromise between affordability and quality, meeting regulatory standards while being more competitively priced than branded rivals.
Additionally, the patent expiration of some blockbuster pharmaceuticals has created chances for generic producers to enter the market with their own variants. The patent cliff phenomenon enables generic businesses to develop cost-effective replacements once the original pharmaceuticals' exclusive market rights expire. As a result, healthcare organizations are increasingly adopting these options to successfully control finances while ensuring patients' access to critical therapies.
Furthermore, the increasing acceptance of generic pharmaceuticals by healthcare professionals and patients fuels the growth of the branded generics industry. Generics have a long history of safety and efficacy, overcoming past concerns about their quality. This trust, combined with the economic benefits, drives stakeholders to adopt branded generics more quickly, resulting in market growth.
The growing desire for cheap healthcare in the Asia-Pacific region is a crucial factor driving the growth of the branded generics market. This region's economies are diverse, with varying healthcare infrastructures and access levels, but many countries share a critical need for cost-effective treatment choices. Branded generics provide an attractive answer by offering pharmaceuticals that are bioequivalent to their branded equivalents but less expensive, making them available to a larger market segment.
The sheer size of the population in Asia-Pacific drives the market for branded generics, as do the associated healthcare concerns. Countries such as India, China, Indonesia, and others suffer significant illness loads while providing diverse levels of healthcare access. Branded generics provide an opportunity to close affordability gaps, ensuring that vital medicines are accessible to a greater number of patients and enhancing overall healthcare outcomes.
Governments throughout the area are beginning to see the economic benefits of supporting generics. Policies and activities that promote the use of generics over branded pharmaceuticals help to lower healthcare costs and distribute resources more efficiently. This governmental support fosters an environment in which pharmaceutical companies can invest in and extend their branded generics portfolios, fulfilling the growing demand in these countries.
Furthermore, the recurring patent expirations of important branded pharmaceuticals provide opportunities for both domestic and multinational pharmaceutical businesses to launch branded generics. This competition promotes innovation while driving down prices, making healthcare more affordable and accessible. As a result, healthcare providers, insurers, and patients are more likely to prefer branded generics for their cost-effectiveness without sacrificing quality, which accelerates market growth.
The competitive landscape of the branded generics market is characterized by the presence of numerous regional and local manufacturers who focus on producing cost-effective alternatives to branded drugs. These companies often operate in emerging markets, leveraging lower production costs and local market knowledge to gain a competitive edge. Additionally, contract manufacturing organizations (CMOs) play a significant role by providing production capabilities for pharmaceutical companies looking to enter the branded generics space without investing in extensive manufacturing infrastructure. The market is also marked by collaborations and partnerships between smaller firms and larger pharmaceutical companies, aiming to expand their product portfolios and market reach. Despite intense competition, opportunities remain abundant for new entrants due to the growing demand for affordable medication options globally.
Some of the prominent players operating in the branded generics market include:
Teva Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries Ltd.
Reddy's Laboratories Ltd.
Lupin Limited
Sanofi
Novartis AG
Pfizer, Inc.
Endo International plc
Mylan N.V.
Fresenius SE & Co KGaA
In May 2024, The FDA continues to receive a constant supply of Abbreviated New Drug Applications (ANDAs) for branded generic drugs. This trend is indicative of a growing branded generics market, driven by the expiration of brand-name drug patents and rising demand for more affordable medication options. The FDA approved several new branded generics, including Edaravone for amyotrophic lateral sclerosis, Emtricitabine and Tenofovir Alafenamide Fumarate for HIV treatment, and Imatinib for chronic myelogenous leukemia. These approvals are likely to improve patient access to these vital treatments while lowering healthcare expenditures.
In September 2023, Novartis, the Swiss pharmaceutical company, disclosed additional financial data for its generics and biosimilars subsidiary Sandoz today (5 September), ahead of a planned spin-off in early October. The proposal was disclosed in August of last year and follows similar measures by Pfizer, Johnson & Johnson, and GlaxoSmithKline.
In November 2023, Rajeev Raghuvanshi underlined the Indian pharmaceutical business must change its thinking and invest more in research and development. The DCGI also emphasized the importance of shifting the focus from volume to value in order to maintain its position as the 'pharmacy of the world.