全球仿制药市场 – 行业趋势及 2030 年预测

仿制药市场分析及规模

世界卫生组织估计，每年有 200 万至 300 万例非黑色素瘤皮肤癌和 132,000 例黑色素瘤皮肤癌。此外，牛皮癣在全世界的发病率从 0.09% 到 11.43% 不等，这是一种严重疾病，影响着全球至少 1 亿人。事实上，局部用药是大多数皮肤病的主要治疗方法，预计未来几年先进局部用药产品的市场将会增长。

Data Bridge Market Research 分析，仿制药市场规模在 2022 年为 6.2202 亿美元，预计到 2030 年将达到 13.2368 亿美元，在 2023 年至 2030 年的预测期内复合年增长率为 9.9%。除了对市场价值、增长率、细分、地理覆盖范围和主要参与者等市场情景的见解外，Data Bridge Market Research 策划的市场报告还包括深度专家分析、患者流行病学、管道分析、定价分析和监管框架。

仿制药市场范围和细分  

Market Definition

Generic medications differ from branded drugs in several aspects, such as the manufacturing process utilized in drug development, excipients, and packaging. Still, they are bioequivalent to branded drugs in terms of strength, dose, quality, safety, performance, and efficacy. Generic drugs become available when the patents for already marketed medications expire. Generic medications, not associated with a particular manufacturer, are often controlled by governments worldwide.

Generic Drug Market Dynamics

Drivers

• Rise in demand for artificial intelligence (AI) technology will bolster the mmarket growth

Robotic process automation uses artificial intelligence (AI) technology to automate routine, rules-based activities. The market's primary operational players can invest more time, effort, and resources in higher-value tasks to this automation. One of the key developments in the market for generic brands that will gain pace in the upcoming years is the use of RPA to ensure compliance with regulations and standards. Pharmaceutical companies frequently utilize RPA and other business process automation tools to carry out high-volume R&D and production tasks. These are the certain factors that propel the market growth.

• India’s thriving pharmaceutical industry propelling India generic drugs market

One of the biggest pharmaceutical markets in the world, India is home to several top pharmaceutical firms. The Indian pharmaceutical sector is ranked third globally in terms of volume and fourteenth globally in terms of value, according to Invest India, an agency of the Indian Government for Investment Promotion and Facilitation. Along with having more than 3,000 pharmaceutical businesses and more than 10,500 production facilities, India also has the most US-FDA compliant pharmaceutical plants outside of the United States.

Opportunities

• Rise in cancer cases will act as an opportunity

According to the International Agency for Research on Cancer's (IARC) 2020 report, which estimated the incidence and mortality of 36 cancers in 185 countries worldwide, an estimated 19.3 million new cases of cancer were diagnosed in 2020 throughout the world, with more than 10.1 million cases of cancer reported in men and 9.3 million cases in women. Additionally, the Global RA Network's 2021 study estimates that more than 350 million individuals worldwide have arthritis. That number is likely to rise due to several variables, including the growing global elderly population. As a result, it is anticipated that the rising prevalence of chronic diseases will increase the need for effective treatment, driving up the growth of the generic drug market throughout the forecast period.

Restraints/Challenges

• Stringent regulations will hinders the growth

Stringent controls, as the FDA assesses the accuracy, side effects, and other substances used in generic pharmaceuticals, are one of the main factors limiting the expansion of generic drugs. Pharmaceutical drugs are typically recalled if the producers don't follow the regulatory requirements. The key elements that influence the quality of generic drugs are purity, potency, stability, and drug release. These should be managed within an appropriate limit, range, or distribution to obtain the desired drug quality. As a result of the strict governmental rules, approval is needed for generic pharmaceuticals, which is projected to hinder market expansion.

This generic drug market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the generic drug market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

COVID-19 Impact on the Generic Drug Market

The COVID-19 epidemic had a significant influence on the generic drug market. Following the COVID-19 pandemic, practically every business initially encountered supply chain interruptions due to various social distancing regulations. The pharmaceutical industry was no exception, which had a detrimental impact on the generic medication market. Later, due to the COVID-19 illness's multiple opportunities to generate drugs to treat this infection, the market witnessed an increase in demand for generic pharmaceuticals. The US Food and Drug Administration (FDA) established the Generic Drug Program to help generic drug producers develop new products by sending written messages, attending meetings early in the development process, and clarifying regulatory requirements throughout application review.

Recent Developments

• In 2020, ANI Pharmaceuticals, Inc., a US-based integrated specialty pharmaceutical company focused on developing, producing, and marketing high-quality branded and generic prescription pharmaceuticals acquired Commercial and Pipeline Generic Products from Amerigen Pharmaceuticals, Ltd. for $52.5 million in cash. The deal has greatly increased ANI Pharmaceuticals, Inc's commercial portfolio and late-stage generic pipeline.

Global Generic Drug Market Scope

The generic drug market is segmented on the basis of type, brand, indication, route of administration, end-users and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Type

• Simple Generics
• Super Generics

Brand

• Pure Generic
• Branded Generic

Indication

• Central Nervous System (CNS)
• Cardiovascular
• Dermatology
• Oncology
• Respiratory
• Others

Route of Administration

• Oral
• Topical
• Parenteral
• Others

End-Users

• Hospitals
• Homecare
• Specialty Clinics
• Others

Distribution Channel

• Hospital Pharmacy
• Online Pharmacy
• Retail Pharmacy

Generic Drug Market Regional Analysis/Insights

The generic drug market is analysed and market size insights and trends are provided by country, type, brand, indication, route of administration, end-users and distribution channel as referenced above.

The countries covered in the generic drug market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

北美在仿制药市场占据主导地位，因为该地区已建立仿制药审批流程框架，且在研发活动方面处于全球领先地位。

预计亚太地区将在 2023 年至 2030 年的预测期内以最高增长率增长，这得益于医疗保健基础设施的不断扩大和政府举措的增加。此外，由于公众对医疗状况的了解不断增加以及该地区人口的老龄化。在亚太地区，中国和印度等国家的贡献比其他国家更大。

报告的国家部分还提供了影响单个市场因素和国内市场监管变化，这些因素和变化会影响市场的当前和未来趋势。下游和上游价值链分析、技术趋势和波特五力分析、案例研究等数据点是用于预测单个国家市场情景的一些指标。此外，在提供国家数据的预测分析时，还考虑了全球品牌的存在和可用性以及它们因来自本地和国内品牌的激烈或稀缺竞争而面临的挑战、国内关税和贸易路线的影响。

竞争格局和仿制药市场份额分析

仿制药市场竞争格局按竞争对手提供详细信息。详细信息包括公司概况、公司财务状况、收入、市场潜力、研发投资、新市场计划、全球影响力、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度、应用主导地位。以上提供的数据点仅与公司对仿制药市场的关注有关。

仿制药市场的一些主要参与者包括：

• Teva Pharmaceuticals Industries Ltd.（以色列）
• Mylan NV，（美国）
• 诺华公司（瑞士）
• 辉瑞公司（美国）
• 太阳制药工业有限公司（印度）
• Fresenius SE & Co. KGaA.，（德国）
• 鲁冰花（印度）
• Endo International plc.，（爱尔兰）
• Aurobindo Pharma（印度）
• 诺华公司（瑞士）
• Hikma Pharmaceuticals PLC.，（英国）
• STADA Arzneimittel AG（德国）
• 礼来公司 (美国)
• 阿斯彭控股 (南非)

SKU-53062