学名药市场 - 预测 2024-2029

2022年学名药市场规模为3,091.47亿美元，预计预测期内复合年增长率为9.62%。

仿製学名药是指与先前核准销售的品牌药具有相同剂型、功效、给药方法和使用目的的处方药。这些相似之处有助于解释生物等效性，即学名药与品牌药的功能相似，并且具有相当的治疗效果。

学名药市场的驱动因素

预计推动学名药市场扩张的关键因素是学名药作为品牌药替代品的成本较低。此外，随着 RPA 越来越频繁地用于确保遵守法规和标准，全球学名药行业的主要竞争对手可能会受益于有利的发展潜力。学名药市场主要参与者的成长策略进一步提振了市场。

慢性病增加

糖尿病和慢性肾臟病（CKD）的流行以及研发活动的活性化预计将有助于预测期内学名药市场的扩大成长。政府措施和临床实验室活动的活性化正在提高消费者对慢性病的认识。学名药市场的开拓预计也将受到主要市场参与企业为解决慢性病而创造的有利报销政策和创新设计的推动。

老年人口增加

由于人口老化，学名药行业预计将成长更快。根据世界卫生组织（WHO）预测，到2030年，六分之一的人口将超过60岁，其中新兴国家占大多数。 2020年至2050年间，80岁及以上的人口预计将增加两倍，达到4.26亿人。老年人经常患有听力损失、白内障、屈光、背部和颈部疼痛、骨关节炎、慢性阻塞性肺病、糖尿病、忧郁症和失智症，导致学名药的使用增加。随着年龄的增长，我们变得更容易同时罹患多种疾病。

学名药产生的收益

《2022 年美国学名药和生物仿製药节省报告》由学名药和生物仿製药的主要行业组织无障碍药物组织 (AAM) 发布，该报告揭示了学名药药和生物仿製药的价值。据估计，与仿製药相比，到 2021 年，使用 FDA核准的学名药学名药将为美国医疗保健系统（包括患者、雇主和纳税人）节省3730 亿美元，这完全是由于市场增长所致。在美国，2021年处方药物中91%是学名药。

口服药物需求快速成长

口服药物是使用和生产最广泛的药物。这是因为它们方便频繁和持续使用，可以由使用者自己管理，并且无痛。该行业的发展受到製造商对口服药物产品日益关注的推动。例如，根据药品专利池（MPP）的公告，2022年1月，口服COVID-19抗病毒药物molnupiravir在105个低收入和中等收入国家生产并分销。据 Oakrum Pharma, LLC 和 ANI Pharmaceuticals 称，美国食品药物管理局(FDA)核准Cystaden® 1（口服无水甜菜碱）粉末 180 克/瓶的通用简化学名药申请 (ANDA)，新药认证授予 180竞争性非专利药疗法的独家经营日。

学名药成本较低

学名药比品牌药更贵，因为学名药申请人不必重复品牌药所需的动物实验和临床（人体）实验来证明安全性和有效性，而且通常价格便宜。因此，在申请学名药时，无需重复证明安全性、有效性所需的动物实验或临床（人体）实验。此外，由于学名药的初始研究成本较低，因此通常以大幅折扣出售，比品牌药的处方成本低 80-85%，同时提供相同的治疗效果，这是学名药的关键驱动因素市场增长，这是经常发生的事情。据 IMS 健康研究所称，2009 年至 2019 年间，学名药为美国医疗保健系统节省了近 2.2 兆美元。

在北美，学名药市场预计将稳定成长。

由于人们的医学素养不断提高和人口老化，北美学名药市场预计将成长最快。北美学名药产业的另一个关键驱动力是製造商更加重视产品创新。例如，梯瓦製药是北美领先的学名药製造商，其产品在美国占九分之一的仿製药处方，在加拿大占六分之一的非专利处方笺。在北美，梯瓦还经营专注于呼吸系统、肿瘤和中枢神经系统 (CNS)（包括神经病学和疼痛治疗）等疾病领域的专业药品品牌。

学名药核准

• 2023年8月，FDA批准了Vyvanse（二甲磺酸赖右安非他明）咀嚼片用于治疗成人中重度暴食症（BED）和6岁及以上患者的注意力不足过动症（ADHD） 。并核准了许多第一个胶囊学名药。
• 2022 年 12 月，多种新药获得 FDA 药物评估与研究中心 (CDER) 的核准。在 FDA 的支持下，当安全、高效、高品质的学名药上市时，患者将能够获得更便宜的治疗选择。清单包括硫酸锌注射液、 Selexipag锭剂和双氯酰胺片剂 USP。

目录

第一章简介

• 市场概况
• 市场定义
• 调查范围
• 市场区隔
• 货币
• 先决条件
• 基准年和预测年时间表

第二章调查方法

• 调查资料
• 先决条件

第三章执行摘要

• 研究亮点

第四章市场动态

• 市场驱动因素
• 市场限制因素
• 波特五力分析
• 产业价值链分析

第五章学名药市场：按类型

• 介绍
• 简单非专利
• 特殊非专利
• 生物相似药

第六章学名药市场：副产品

• 介绍
• 低分子
• 高分子

第七章学名药市场：依应用分类

• 介绍
• 中枢神经系统疾病
• 呼吸系统疾病
• 荷尔蒙与相关疾病
• 心血管疾病
• 癌症
• 其他的

第八章学名药市场：按分销管道

• 介绍
• 网路药房
• 零售药房
• 医院药房

第九章学名药市场：按地区

• 介绍
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 南美洲
  • 巴西
  • 阿根廷
  • 其他的
• 欧洲
  • 英国
  • 德国
  • 法国
  • 西班牙
  • 其他的
• 中东/非洲
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 以色列
  • 其他的
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 韩国
  • 印尼
  • 泰国
  • 其他的

第十章竞争环境及分析

• 主要企业及策略分析
• 市场占有率分析
• 合併、收购、协议和合作
• 供应商竞争力矩阵

第十一章 公司简介

• Teva Pharmaceutical Industries
• Taj Pharmaceuticals
• ScieGen Pharmaceuticals
• Brown & Burk
• UPM Pharmaceuticals
• Generic Pharma International
• Par Pharmaceutical
• Mallinckrodt
• AlvionPharma
• Sun Pharmaceutical Industries Ltd.
• Lupin

The generic pharmaceuticals market was valued at US$309.147 billion in 2022 and is expected to grow at a CAGR of 9.62% during the forecast period.

A generic medicine is a prescription medication that is made to be identical to a brand-name drug that has previously been approved for marketing in terms of dose form, potency, mode of administration, and intended purpose. These parallels serve to illustrate bioequivalence, which states that a generic drug functions similarly to a brand-name drug and has a comparable therapeutic benefit.

Driving factors for the generic pharmaceuticals market

A significant element anticipated to fuel the expansion of the generic pharmaceutical market is the cheap cost of generics as an alternative to branded medications. Additionally, the leading competitors in the worldwide generic pharmaceutical industry benefit from lucrative development potential if RPA is used more frequently to assure regulatory and standards compliance. The generic pharmaceutical market's primary operational players' growth strategies are further boosting the market.

Increasing prevalence of chronic diseases

The prevalence of diabetes and chronic kidney disease (CKD), and higher R&D activities are all expected to contribute to an increase in the generic pharmaceutical market growth during the forecast period. Government efforts and growth in clinical laboratory activity lead to consumers' awareness of the growing prevalence of chronic diseases. The development of the generic pharmaceutical market is also projected to be fueled by favorable reimbursement policies and innovative designs produced by major industry participants to deal with chronic illnesses.

Growth in geriatric population

The aging population is predicted to cause the generic pharmaceutical industry to grow more swiftly. According to the World Health Organisation, 1 in 6 people will be 60 or older by 2030, with emerging nations accounting for the majority of this increase. The number of people 80 or older is anticipated to triple between 2020 and 2050, reaching 426 million. Elderly people frequently suffer from hearing loss, cataracts and refractive errors, back and neck pain and osteoarthritis, chronic obstructive pulmonary disease, diabetes, depression, and dementia which leads to the growing use of generic pharmaceuticals. As people age, they become increasingly susceptible to many illnesses at once.

Revenue generated by generic and biosimilar drugs

The 2022 U.S. Generic & Biosimilar Medicines Savings Report, which highlights the value of generic and biosimilar medications, was produced by the Organisation for Accessible Medicines (AAM), the main trade organization for generic and biosimilar producers. The estimate shows that utilizing FDA-approved generic and biosimilar pharmaceuticals will save the American healthcare system, including patients, employers, and taxpayers, $373 billion in 2021 which is solely due to growth in the generic pharmaceutical market. In the United States, 91% of prescriptions filled in 2021 were for generic medications, yet those prescriptions only accounted for 18.2% of the nation's drug expenditure.

Surging demand for oral medications

Oral drugs are the most widely used and produced medications because they are convenient for frequent and sustained usage, may be administered by the users themselves, and are painless. The sector is fueled by the growing focus of manufacturers on providing oral medications. For instance, in January 2022, the oral COVID-19 antiviral drug molnupiravir was produced and distributed in 105 low- and middle-income countries, according to an announcement made by the Medicines Patent Pool (MPP). In February 2022, The U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane®1 (betaine anhydrous for oral solution) Powder in a 180 gm bottle and granted Competitive Generic Therapy of 180 days of exclusivity, according to Oakrum Pharma, LLC and ANI Pharmaceuticals.

Lower cost of generic pharmaceuticals

Generic pharmaceuticals frequently cost less than their brand-name equivalents because generic drug applicants do not have to repeat the animal and clinical (human) experiments that were required for brand-name treatments to show safety and efficacy. The application is known as an abbreviated new drug application because of the compressed process. Moreover, due to lower initial research costs, generic drugs are frequently sold at substantial discounts, typically between 80 and 85% less than the cost of the brand-name prescription, while still providing the same therapeutic effect which is the major growth driver for generic pharmaceutical market growth. According to the IMS Health Institute, generic drugs saved the American healthcare system close to $2.2 trillion between 2009 and 2019.

In North America, it is projected that the generic pharmaceuticals market will grow steadily.

North America is expected to have the fastest growth in the generic pharmaceutical market due to increased medical literacy among the public and the region's aging population. Another key driver of the North American generic pharmaceutical industry is the rising focus on manufacturers on product innovation. For instance, Teva is the top manufacturer of generic medications in North America, and its products are used to fill 1 in 9 generic prescriptions in the US and 1 in 6 in Canada. In North America, Teva also operates a specialty medication branded business that specializes in diseases of the respiratory, oncological, and central nervous system (CNS) (including neurology and pain treatment), and other disease areas.

Generic pharmaceuticals approval

• In August 2023, the FDA authorized a number of the first generic versions of Vyvanse (lisdexamfetamine dimesylate) chewable tablets and capsules for the treatment of moderate to severe binge-eating disorder (BED) in adults as well as attention-deficit/hyperactivity disorder (ADHD) in patients six years of age and older.
• In December 2022, a wide variety of new medication items were approved by the FDA's Centre for Medication Evaluation and Research (CDER). When safe, efficient, high-quality generic alternatives are introduced to the market with the help of the FDA, patients have access to more inexpensive treatment options. The list included Zinc Sulfate Injections, Selexipag Tablets, and Dichlorphenamide Tablets USP.

Market Key Developments

• In September 2022, Zenara Pharma, based in Hyderabad, announced that it has become the first company in the nation to roll out the Nirmatrelvir and Ritonavir tablets combi pack, more than a month after receiving emergency use authorization (EUA) from the Indian drug regulator for its generic version of Pfizer's Covid-19 oral drug Paxlovid.
• In May 2022, Aurobindo Pharma stated that its wholly-owned subsidiary Eugia Pharma Specialties Ltd has obtained final clearance from the US health agency to produce and sell its generic version of the cancer treatment Bortezomib for injection.
• In May 2022, Gland Pharma announced that it had introduced the cancer medication Bortezomib for Injection to the US market. According to a statement from the pharmaceutical business, the company released the medicine in the US market through a partner that was given approval by the US Food & Drug Administration (USFDA).

Segmentation:

By Type

• Simple Generics
• Specialty Generics
• Biosimilars

By Product

• Small Molecule
• Large Molecule

By Application

• Central Nervous System Disorders
• Respiratory Disorders
• Hormones & Related Disorders
• Cardiovascular Disorders
• Cancer
• Other

By Distribution Channel

• Online Pharmacies
• Retail Pharmacies
• Hospital Pharmacies

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• United Kingdom
• Germany
• France
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Israel
• Others
• Asia Pacific
• Japan
• China
• India
• South Korea
• Indonesia
• Thailand
• Others

TABLE OF CONTENTS

1. INTRODUCTION

• 1.1. Market Overview
• 1.2. Market Definition
• 1.3. Scope of the Study
• 1.4. Market Segmentation
• 1.5. Currency
• 1.6. Assumptions
• 1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

• 2.1. Research Data
• 2.2. Assumptions

3. EXECUTIVE SUMMARY

• 3.1. Research Highlights

4. MARKET DYNAMICS

• 4.1. Market Drivers
• 4.2. Market Restraints
• 4.3. Porter's Five Force Analysis
  • 4.3.1. Bargaining Power of Suppliers
  • 4.3.2. Bargaining Power of Buyers
  • 4.3.3. Threat of New Entrants
  • 4.3.4. Threat of Substitutes
  • 4.3.5. Competitive Rivalry in the Industry
• 4.4. Industry Value Chain Analysis

5. GENERIC PHARMACEUTICALS MARKET, BY TYPE

• 5.1. Introduction
• 5.2. Simple Generics
• 5.3. Specialty Generics
• 5.4. Biosimilars

6. GENERIC PHARMACEUTICALS MARKET, BY PRODUCT

• 6.1. Introduction
• 6.2. Small Molecule
• 6.3. Large Molecule

7. GENERIC PHARMACEUTICALS MARKET, BY APPLICATION

• 7.1. Introduction
• 7.2. Central Nervous System Disorders
• 7.3. Respiratory Disorders
• 7.4. Hormones & Related Disorders
• 7.5. Cardiovascular Disorders
• 7.6. Cancer
• 7.7. Other

8. GENERIC PHARMACEUTICALS MARKET, BY DISTRIBUTION CHANNEL

• 8.1. Introduction
• 8.2. Online Pharmacies
• 8.3. Retail Pharmacies
• 8.4. Hospital Pharmacies

9. GENERIC PHARMACEUTICALS MARKET, BY GEOGRAPHY

• 9.1. Introduction
• 9.2. North America
  • 9.2.1. United States
  • 9.2.2. Canada
  • 9.2.3. Mexico
• 9.3. South America
  • 9.3.1. Brazil
  • 9.3.2. Argentina
  • 9.3.3. Others
• 9.4. Europe
  • 9.4.1. United Kingdom
  • 9.4.2. Germany
  • 9.4.3. France
  • 9.4.4. Spain
  • 9.4.5. Others
• 9.5. The Middle East and Africa
  • 9.5.1. Saudi Arabia
  • 9.5.2. UAE
  • 9.5.3. Israel
  • 9.5.4. Others
• 9.6. Asia Pacific
  • 9.6.1. Japan
  • 9.6.2. China
  • 9.6.3. India
  • 9.6.4. South Korea
  • 9.6.5. Indonesia
  • 9.6.6. Thailand
  • 9.6.7. Others

10. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 10.1. Major Players and Strategy Analysis
• 10.2. Market Share Analysis
• 10.3. Mergers, Acquisitions, Agreements, and Collaborations
• 10.4. Vendor Competitiveness Matrix

11. COMPANY PROFILES

• 11.1. Teva Pharmaceutical Industries
• 11.2. Taj Pharmaceuticals
• 11.3. ScieGen Pharmaceuticals
• 11.4. Brown & Burk
• 11.5. UPM Pharmaceuticals
• 11.6. Generic Pharma International
• 11.7. Par Pharmaceutical
• 11.8. Mallinckrodt
• 11.9. AlvionPharma
• 11.10. Sun Pharmaceutical Industries Ltd.
• 11.11. Lupin