세계 제네릭 의약품 시장 예측 : 제품 유형별, 투여 경로별, 약제 클래스별, 적응증별, 용도별, 유통 채널별, 최종 사용자별, 지역별 분석(-2030년)

According to Stratistics MRC, the Global Generic Drug Market is accounted for $396.8 billion in 2023 and is expected to reach $604.5 billion by 2030 growing at a CAGR of 6.2% during the forecast period. Generic medications are pharmaceuticals that, in terms of their active components, dosage form, strength, mode of administration, quality, safety, and intended use, are bioequivalent to name-brand or innovator medications. They are made to have the same therapeutic effect as the original brand-name medicine, but they are often marketed for less money. Offering more economical substitutes for name-brand prescriptions is one of the main goals of generic medications. They aid in lowering medical expenses for patients, insurers, and healthcare systems.

According to the Indian Pharmaceutical Industry Report published in November 2021 by IBEF, India is the world's top supplier of generic pharmaceuticals. The Indian pharmaceutical industry supplies 40% of the generic demand in the United States and 25% of all pharmaceuticals in the United Kingdom.

Market Dynamics:

Driver:

Growing healthcare expenditure

Cost containment is given more attention when healthcare expenses grow. For consumers, insurers, and healthcare professionals, generic medications are increasingly chosen since they are often less expensive than name-brand medications. The desire for affordable medicines has grown, which is good for the generic drug business. The growth of the healthcare industry, including more hospital admissions, outpatient visits, and prescription drug use, is frequently a result of growing healthcare costs. Moreover the usage of generic medications may significantly reduce the cost of healthcare systems, especially publicly financed programs like Medicaid and Medicare. These programs can supply vital pharmaceuticals while better controlling their finances by selecting generic substitutes thus propelling the growth of the market.

Restraint:

Strict regulations

One of the key factors restricting the growth of generic medications is the strict restrictions, as the FDA evaluates the accuracy, adverse effects, and other ingredients used in generic pharmaceuticals. If the manufacturers don't adhere to regulatory criteria, pharmaceutical medications are frequently recalled. Purity, potency, stability, and drug release are the main factors that affect how well generic medications perform. To achieve the desired medication quality, they should be regulated within a suitable limit, range, or distribution. The tight government regulations that need clearance for generic medications are anticipated to obstruct market development.

Opportunity:

Patent expirations

When a brand-name medicine's patent runs out, generic drug producers can start creating and selling their copies of the drug. Due to increased market competition, customers and healthcare systems may be able to save money. Patients can acquire vital treatments more affordably with the help of generic pharmaceuticals. This is crucial for people who would not have been able to purchase the brand-name medication and the availability of generic treatments may increase the market for some pharmaceuticals. Patients who previously couldn't afford the name-brand medication may now seek therapy, expanding the market's total size

Threat:

Complex generic development

Complex generic development, which entails creating generic copies of more complex and difficult treatments including biologics and complex formulations, can have a number of detrimental implications on the generic drug industry. Complex generic drug development and approval, especially for biosimilars (generic analogues of biologic drugs), may be a time-consuming and resource-intensive procedure. This additional timeframe delays their arrival into the market, thereby depriving patients of affordable options for an extended period of time. Regulation barriers and delays may result from the demanding criteria for proving bioequivalence and resemblance to the reference biologic which impedes the growth of the market.

COVID-19 Impact

Due to lockdowns, travel restrictions, and issues with the manufacture of active pharmaceutical ingredients (APIs) and completed goods, the generic medicine sector, like the larger pharmaceutical industry, experienced supply chain disruptions. Restrictions on international commerce had an impact on the availability of generic medications because many APIs are obtained from nations like China and India. Demand for several medicines, including as antibiotics, COVID-19 treatment pharmaceuticals, and antiviral treatments, increased as a result of the pandemic. To address the expanding demand for healthcare, generic medicine makers have to react to growing orders.

The super generics segment is expected to be the largest during the forecast period

The super generics segment is estimated to have a lucrative growth, because the super generics, sometimes known as "enhanced generics" or "next-generation generics," are a modern subset of generic medications that attempt to provide certain benefits above more conventional generics. Improved effectiveness, safety, and convenience are possible benefits. Super generics are created to alleviate some of the drawbacks of traditional generics while still being reasonably priced. When compared to conventional generic versions, super generics may have advantages in terms of improved therapeutic effectiveness and safety profiles which drives the market growth.

The injectable segment is expected to have the highest CAGR during the forecast period

The injectable segment is anticipated to witness the highest CAGR growth during the forecast period, as these are provided through injection, often into the circulation or directly into particular tissues. These medications are essential in a variety of healthcare settings, such as hospitals, clinics, and home care and they are used to treat a wide spectrum of medical disorders. A wide variety of drugs, including antibiotics, analgesics, hormones, vaccinations, and more, are available as injectable generics. Infections, chronic illnesses, and critical care scenarios are just a few of the problems they are used to treat and control. When compared to name-brand injectable medications, they can provide considerable cost savings, lowering the cost and increasing accessibility to healthcare.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period owing to rising medical knowledge among the populace and the region's aging demographic; In the Asia-Pacific area, countries like China and India contribute more than other countries do. A research by the International Institute for Population Sciences (IIPS) estimates that in January 2021, there were around 75 million chronically unwell Indians over the age of 60. Cardiovascular disease, hypertension, and diabetes affect roughly 20 million individuals worldwide. Thus, the increased incidence of chronic illnesses in the nation would increase the need for affordable therapies, propelling the market under study. As a result of the aforementioned reasons, the Asia-Pacific region is anticipated to have quicker growth.

Region with highest CAGR:

Europe is projected to have the highest CAGR over the forecast period, owing to reasons including aging populations, healthcare systems' efforts to control costs, and the expiration of brand-name pharmaceuticals' patents. In the European Union, generic medicine regulation is heavily influenced by the European Medicines Agency (EMA). To be approved, generic medications must adhere to strict quality, safety, and effectiveness requirements. Generic medications are safe and effective substitutes for their brand-name equivalents thanks to the regulatory framework. The emphasis on biosimilars (generic copies of biologic pharmaceuticals), the growth of the over-the-counter (OTC) generic drug industry, and the influence of digital health technology on medication are a few prominent developments in the European generic drug business.

Key players in the market:

Some of the key players profiled in the Generic Drug Market include: Pfizer Inc., Sun Pharmaceutical Industries Ltd., Novartis AG, Mylan NV, Teva Pharmaceuticals Industries Ltd., Endo International plc, Lupin, Aurobindo Pharma, Hikma Pharmaceuticals PLC, STADA Arzneimittel AG, Eli Lilly and Company, Aspen Holdings, Fresenius SE & Co. KGaA., GlaxoSmithKline plc, Viatris Inc, Amneal Pharmaceuticals, Inc, Cipla Ltd, Abbott Laboratories, Sanofi, Baxter International Inc. and AbbVie Inc.

Key Developments:

In October 2023, Pfizer presents new data at IDWeek 2023 Highlighting advances in prevention and treatment of certain respiratory illnesses and Other Infectious Diseases. Presentations showcase diversity and momentum of Pfizer's growing portfolio of vaccines and anti-infectives

In October 2023, Novartis presents new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer. Key data from the Phase III PSMAfore trial has been selected for a Presidential session.

In October 2023, Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment. Collaboration leverages the innovative R&D and commercial expertise of both companies.

In September 2023, Teva Presents Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023.

Product Types Covered:

• Super Generics
• Biosimilar Generics
• Simple Generic

Route of Administrations Covered:

• Injectable
• Topical
• Oral
• Sublingual
• Other Routes of Administrations

Drug Classes Covered:

• Analgesics
• Antipyretic
• Antihistamines
• Antihypertensive
• Antibiotics
• Antidiabetic
• Other Drug Classes

Indications Covered:

• Gastroenterology
• Pulmonology
• Diabetology
• Cardiology
• Dermatology
• Oncology
• Other Indications

Applications Covered:

• Infectious Diseases
• Cardiovascular Diseases
• Diabetes
• Cancer
• Gastric Diseases
• Musculoskeletal Diseases
• Other Applications

Distribution Channels Covered:

• Hospital Pharmacies
• Online Providers
• Retail Pharmacies
• Other Distribution Channels

End Users Covered:

• Hospitals
• Specialty Clinics
• Multi-Specialty Clinics
• Homecare
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 Application Analysis
• 3.8 End User Analysis
• 3.9 Emerging Markets
• 3.10 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Generic Drug Market, By Product Type

• 5.1 Introduction
• 5.2 Super Generics
• 5.3 Biosimilar Generics
• 5.4 Simple Generic

6 Global Generic Drug Market, By Route of Administration

• 6.1 Introduction
• 6.2 Injectable
• 6.3 Topical
• 6.4 Oral
• 6.5 Sublingual
• 6.6 Other Routes of Administrations

7 Global Generic Drug Market, By Drug Class

• 7.1 Introduction
• 7.2 Analgesics
• 7.3 Antipyretic
• 7.4 Antihistamines
• 7.5 Antihypertensive
• 7.6 Antibiotics
• 7.7 Antidiabetic
• 7.8 Other Drug Classes

8 Global Generic Drug Market, By Indication

• 8.1 Introduction
• 8.2 Gastroenterology
• 8.3 Pulmonology
• 8.4 Diabetology
• 8.5 Cardiology
• 8.6 Dermatology
• 8.7 Oncology
• 8.8 Other Indications

9 Global Generic Drug Market, By Application

• 9.1 Introduction
• 9.2 Infectious Diseases
• 9.3 Cardiovascular Diseases
• 9.4 Diabetes
• 9.5 Cancer
• 9.6 Gastric Diseases
• 9.7 Musculoskeletal Diseases
• 9.8 Other Applications

10 Global Generic Drug Market, By Distribution Channel

• 10.1 Introduction
• 10.2 Hospital Pharmacies
• 10.3 Online Providers
• 10.4 Retail Pharmacies
• 10.5 Other Distribution Channels

11 Global Generic Drug Market, By End User

• 11.1 Introduction
• 11.2 Hospitals
• 11.3 Specialty Clinics
• 11.4 Multi-Specialty Clinics
• 11.5 Homecare
• 11.6 Other End Users

12 Global Generic Drug Market, By Geography

• 12.1 Introduction
• 12.2 North America
  • 12.2.1 US
  • 12.2.2 Canada
  • 12.2.3 Mexico
• 12.3 Europe
  • 12.3.1 Germany
  • 12.3.2 UK
  • 12.3.3 Italy
  • 12.3.4 France
  • 12.3.5 Spain
  • 12.3.6 Rest of Europe
• 12.4 Asia Pacific
  • 12.4.1 Japan
  • 12.4.2 China
  • 12.4.3 India
  • 12.4.4 Australia
  • 12.4.5 New Zealand
  • 12.4.6 South Korea
  • 12.4.7 Rest of Asia Pacific
• 12.5 South America
  • 12.5.1 Argentina
  • 12.5.2 Brazil
  • 12.5.3 Chile
  • 12.5.4 Rest of South America
• 12.6 Middle East & Africa
  • 12.6.1 Saudi Arabia
  • 12.6.2 UAE
  • 12.6.3 Qatar
  • 12.6.4 South Africa
  • 12.6.5 Rest of Middle East & Africa

13 Key Developments

• 13.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 13.2 Acquisitions & Mergers
• 13.3 New Product Launch
• 13.4 Expansions
• 13.5 Other Key Strategies

14 Company Profiling

• 14.1 Pfizer Inc.
• 14.2 Sun Pharmaceutical Industries Ltd.,
• 14.3 Novartis AG
• 14.4 Mylan NV
• 14.5 Teva Pharmaceuticals Industries Ltd.
• 14.6 Endo International plc
• 14.7 Lupin
• 14.8 Aurobindo Pharma
• 14.9 Hikma Pharmaceuticals PLC
• 14.10 STADA Arzneimittel AG
• 14.11 Eli Lilly and Company
• 14.12 Aspen Holdings
• 14.13 Fresenius SE & Co. KGaA.
• 14.14 GlaxoSmithKline plc
• 14.15 Viatris Inc
• 14.16 Amneal Pharmaceuticals, Inc
• 14.17 Cipla Ltd
• 14.18 Abbott Laboratories
• 14.19 Sanofi
• 14.20 Baxter International Inc.
• 14.21 AbbVie Inc.