제네릭 의약품 시장 : 예측(2024-2029년)

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