首頁 > 市場調查報告書 > 製藥

非專利藥

市場調查報告書

商品編碼

1425114

學名藥市場 - 預測 2024-2029

Generic Pharmaceuticals Market - Forecasts from 2024 to 2029

出版日期: 2024年01月24日 | 出版商:

Knowledge Sourcing Intelligence | 英文 140 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

2022年學名藥市場規模為3,091.47億美元，預計預測期內複合年成長率為9.62%。

仿製學名藥是指與先前核准銷售的品牌藥具有相同劑型、功效、給藥方法和使用目的的處方藥。這些相似之處有助於解釋生物等效性，即學名藥與品牌藥的功能相似，並且具有相當的治療效果。

學名藥市場的促進因素

預計推動學名藥市場擴張的關鍵因素是學名藥作為品牌藥替代品的成本較低。此外，隨著 RPA 越來越頻繁地用於確保遵守法規和標準，全球學名藥行業的主要競爭對手可能會受益於有利的發展潛力。學名藥市場主要參與者的成長策略進一步提振了市場。

慢性病增加

糖尿病和慢性腎臟病（CKD）的流行以及研發活動的活性化預計將有助於預測期內學名藥市場的擴大成長。政府措施和臨床實驗室活動的活性化正在提高消費者對慢性病的認知。學名藥市場的開拓預計也將受到主要市場參與企業為解決慢性病而創造的有利報銷政策和創新設計的推動。

老年人口增加

由於人口老化，學名藥行業預計將成長更快。根據世界衛生組織（WHO）預測，到2030年，六分之一的人口將超過60歲，其中新興國家佔大多數。 2020年至2050年間，80歲及以上的人口預計將增加兩倍，達到4.26億人。老年人經常患有聽力損失、白內障、屈光、背部和頸部疼痛、骨關節炎、慢性阻塞性肺病、糖尿病、憂鬱症和失智症，導致學名藥的使用增加。隨著年齡的成長，我們變得更容易同時罹患多種疾病。

學名藥產生的收益

《2022 年美國學名藥和生物學名藥節省報告》由學名藥和生物學名藥的主要行業組織無障礙藥物組織 (AAM) 發布，該報告揭示了學名藥藥和生物學名藥的價值。據估計，與學名藥相比，到 2021 年，使用 FDA核准的學名藥學名藥將為美國醫療保健系統（包括患者、雇主和納稅人）節省3730 億美元，這完全是由於市場成長所致。在美國，2021年處方藥物中91%是學名藥。

口服藥物需求快速成長

口服藥物是使用和生產最廣泛的藥物。這是因為它們方便頻繁和持續使用，可以由使用者自己管理，並且無痛。該行業的發展受到製造商對口服藥物產品日益關注的推動。例如，根據藥品專利池（MPP）的公告，2022年1月，口服COVID-19抗病毒藥物molnupiravir在105個低收入和中等收入國家生產並分銷。據 Oakrum Pharma, LLC 和 ANI Pharmaceuticals 稱，美國食品藥物管理局(FDA)核准Cystaden® 1（口服無水甜菜鹼）粉末 180 克/瓶的通用簡化學名藥申請 (ANDA)，新藥認證授予 180競爭性非專利藥療法的獨家經營日。

學名藥成本較低

學名藥比品牌藥更貴，因為學名藥申請人不必重複品牌藥所需的動物實驗和臨床（人體）實驗來證明安全性和有效性，而且通常價格便宜。因此，在申請學名藥時，無需重複證明安全性、有效性所需的動物實驗或臨床（人體）實驗。此外，由於學名藥的初始研究成本較低，因此通常以大幅折扣出售，比品牌藥的處方成本低 80-85%，同時提供相同的治療效果，這是學名藥的關鍵促進因素市場成長，這是經常發生的事情。據 IMS 健康研究所稱，2009 年至 2019 年間，學名藥為美國醫療保健系統節省了近 2.2 兆美元。

在北美，學名藥市場預計將穩定成長。

由於人們的醫學素養不斷提高和人口老化，北美學名藥市場預計將成長最快。北美學名藥產業的另一個關鍵驅動力是製造商更加重視產品創新。例如，梯瓦製藥是北美領先的學名藥製造商，其產品在美國佔九分之一的學名藥處方，在加拿大佔六分之一的非專利處方箋。在北美，梯瓦還經營專注於呼吸系統、腫瘤和中樞神經系統 (CNS)（包括神經病學和疼痛治療）等疾病領域的專業藥品品牌。

學名藥核准

2023年8月，FDA批准了Vyvanse（二甲磺酸賴右安非他明）咀嚼片用於治療成人中重度暴食症（BED）和6歲及以上患者的注意力不足過動症（ADHD）。並核准了許多第一個膠囊學名藥。
2022 年 12 月，多種新藥獲得 FDA 藥物評估與研究中心 (CDER) 的核准。在 FDA 的支持下，當安全、高效、高品質的學名藥上市時，患者將能夠獲得更便宜的治療選擇。清單包括硫酸鋅注射液、 Selexipag錠劑和雙氯醯胺片劑 USP。

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

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