The demand for super generics in Europe was valued at USD 11.4 billion in 2022 and is expected to reach USD 14.2 billion by 2033. It is estimated to surge at a CAGR of close to 2.0% over the forecast period from 2023 to 2033. The anti-diabetic segment held 13.3% in terms of value share and topped Europe in the drug class category in 2022.
| Attributes | Key Insights |
|---|---|
| Europe Super Generics Value (2022) | USD 11.4 billion |
| Europe Super Generics Estimated Revenue (2023E) | USD 11.6 billion |
| Europe Super Generics Projected Revenue (2033F) | USD 14.2 billion |
| Value-based CAGR (2023 to 2033) | 2.0% |
Super generics represent a remarkable opportunity due to their innovative, low-risk nature, high quality, reduced side effects, and cost-effectiveness. They offer a compelling alternative to bio-generics.
The success of super generics hinges on a company's ability to foster innovation. To develop super generics effectively, it is imperative to harness formulation expertise fully. The formulation should not only match the quality of branded drugs but also be more cost-efficient than generics.
The pharmaceutical landscape is changing dramatically as the number of expiring patents for small molecule drugs is expected to double by 2033. This impending wave of expiring drugs brings significant opportunities for generic manufacturers.
Generics, which are bioequivalent to their branded counterparts, are typically less expensive. These would play a critical role in expanding access to essential medicines and reducing healthcare costs. Among the expired drugs, specific therapeutic categories stand out with promising potential.
The expiration of drug patents in these categories will stimulate competition and lead to the development of cost-effective generic alternatives. This can improve patient access to life-saving oncology treatments, essential drugs for neurological disorders, and systemic anti-infectives to combat infectious diseases. In summary, the imminent surge in expiring small molecule drugs is set to create a favorable environment for super generic drug manufacturers.
The practice of pay-for-delay or reverse payment settlements in the pharmaceutical business has garnered significant attention and criticism for its implications on consumer costs and healthcare accessibility. In these agreements, generic manufacturers agree to postpone the launch of their lower-cost generic versions of brand-name drugs.
They aim to do so in exchange for brand drug manufacturers not introducing their authorized generics during exclusivity. While these deals can seem to be mutually beneficial business strategies for the involved parties, they have far-reaching and adverse effects on consumers and the broader healthcare system.
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The super generics space in Europe generated around 34.4% of the overall Europe-authorized generics business in 2022 and was valued at USD 33.1 billion. The rising prevalence of chronic diseases in Europe presents a multifaceted healthcare challenge of growing concern.
| Historical Value (2022) | USD 11.4 billion |
|---|---|
| Projected Value-based CAGR (2023 to 2033) | 2.0% |
Several interconnected factors contribute to this trend. An aging population is a significant driver, as advancing age is a crucial risk factor for countless chronic conditions. As Europe's demographic makeup shifts toward older people, the burden of chronic diseases escalates.
According to the Cancer Atlas, Europe experienced an estimated 3.9 million new instances of cancer and 1.9 million cancer-related fatalities in 2018. Among these, the most prevalent types of cancer were breast cancer (523,000 new cases, accounting for 13% of all cancer cases), colorectal cancer (500,000 cases, 13%), lung cancer (470,000 cases, 12%), and prostate cancer (450,000 cases, 12%).
Promising therapeutic areas, including the central nervous system & pain management, cardiovascular health, anti-infective, respiratory care, and oncology, present expansive opportunities for super generics in Europe. The recent surge in approvals of generic medications in the region signifies a pivotal shift in the continent's pharmaceutical landscape.
A primary driver of this trend is the expiration of patents on multiple brand-name drugs, which opens the door for generic drug manufacturers to introduce equivalent versions. Due to the above factors, the super generics ecosystem in Europe is projected to expand at a CAGR of 2.0% in the forecast period.
The table below provides the latest trends observed in the Europe super generics space, growth obstacles, and upcoming opportunities. Business strategies for pushing super generics sales in Europe enable stakeholders to invest in the right area and gain profit.
| Attributes | Key Factors |
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| Latest Trends |
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Principal Consultant
The table below shows the growth potential of super generics in Europe. CAGRs of the top 5 countries are provided. Out of the 5, Spain will likely lead the field of super generics in Europe by exhibiting a CAGR of 2.7% from 2023 to 2033. France, Poland, and Germany are expected to witness super generics sales at the CAGRs of 1.9%, 1.8%, and 1.8%, respectively.
| Countries | Value CAGR (2033) |
|---|---|
| Poland | 1.8% |
| United Kingdom | 1.5% |
| Germany | 1.8% |
| Spain | 2.7% |
| France | 1.9% |
| Nordics | 1.0% |
Poland occupied around 12.2% of the Europe super generics business share in 2022. Poland's pharmaceutical space has been steadily growing and evolving, making it an increasingly lucrative opportunity for generics. With a robust and technologically advanced pharmaceutical sector, Poland has become a hub for the production of super generic drugs, contributing significantly to its advanced businesses.
The country's strategic geographical location within Europe makes it an attractive base for pharmaceutical companies accessing Eastern and Western Europe. Furthermore, Poland's commitment to improving its business and research environment can enhance the country's attractiveness to pharmaceutical companies. This includes the establishment of high-tech business clusters, fostering collaboration between academia & businesses, and stimulating research through public procurement.
As the country continues to invest in innovation and technology, its position as a favorable destination for pharmaceutical and super generics companies is set to strengthen. It is expected to offer significant growth opportunities in Poland.
The United Kingdom is the second leading country in Europe's super generic space. The super generics business in the United Kingdom is set to surge at a decent CAGR of 1.5% over the forecast period.
Pharmaceutical innovators are actively working to protect their intellectual property and product brands by seeking patent extensions. In contrast, generic producers aggressively pursue opportunities in this evolving landscape, aiming to capture a significant share by offering affordable alternatives to these soon-to-be off-patent drugs. In the United Kingdom, the generics business is experiencing significant transformation due to shifts in the competitive landscape.
Integrating digital health technologies, such as mobile applications for patient compliance or remote monitoring, is becoming progressively relevant in the country’s healthcare system. Super generics companies that can provide these value-added services can have a competitive advantage. Educating healthcare specialists and patients about the aids and differences between generic drugs & standard generic or branded drugs is critical for acceptance.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is accountable for regulating medicines in the country. Any generic drug entering the country must meet strict regulatory necessities for safety, quality, and effectiveness.
Accessing the National Health Service (NHS) formulary and receiving reimbursement is essential to the success of super generic medicines in the United Kingdom. It is vital to demonstrate cost-effectiveness and clinical benefits compared with currently available options.
The United Kingdom's departure from the European Union (Brexit) has led to regulatory courses, supply chain dynamics, and access changes. Super generics drug manufacturers are set to adapt to these new circumstances to create new opportunities.
In 2022, Germany held a significant share of the Europe super generics space and contributed around USD 1.1 billion. The ongoing and progressive aging of Germany's population is anticipated to drive the demand for medical treatments, particularly for chronic diseases.
The demographic shift is poised to benefit not only producers of specialty pharmaceutical products but also manufacturers of generic drugs. Germany's pharmaceutical and healthcare sector is subject to stringent regulations, although legislative pressure on pharmaceutical companies to reduce drug prices for end-consumers is relatively moderate.
Educating healthcare specialists and patients about the remunerations and differences between generic and standard generic or branded drugs is significant for acceptance. In Germany, the Federal Institute for Pharmaceuticals and Medical Devices (BfArM) and the Paul-Ehrlich Institute (PEI) oversee the approval and rule of pharmaceutical products. Any generic drug inflowing into the sector must meet regulatory safety, quality, and effectiveness requirements.
Accessing the compulsory health insurance form and receiving reimbursement is essential for the success of the super generics business in Germany. It is vital to demonstrate cost-effectiveness and clinical benefits compared with currently available options.
Germany has a strict health technology assessment (HTA) process for new drugs, including super generics. Business entry must demonstrate clinical benefit and cost-effectiveness through HTA assessments.
Spain is estimated to record a considerable super generics demand at a CAGR of 2.7% in the anticipated time frame. The concept of super generics is gaining immense popularity in Spain. These generic drugs are set to offer other benefits over standard generic drugs, such as enhanced effectiveness, reduced side properties, or substitute delivery mechanisms.
Several pharmaceutical companies, both local and global, have been involved in the growth and distribution of generic medicines in Spain. A handful of firms are established manufacturers of generic drugs, while others specialize in developing improved versions of prevailing drugs. Companies are estimated to focus on unveiling improved versions of drugs in therapeutic classes, such as central nervous system, cardiovascular, cancer, and respiratory diseases.
The Spain super generic business is very competitive and has several long-standing companies. Super generics face competition from standard generics, other advanced formulations, and specialty pharmaceuticals.
Price is an essential factor in the pharmaceutical sector, comprising generic medicines. These products must offer a cost-effective alternative to standard branded and generic drugs to be approved.
The table below highlights the demand for super generics in Europe by indication, distribution channel, drug class, and route of administration. Under indication, the cardiology segment is expected to surge at a CAGR of 1.3% in the assessment period.
The oral segment, while smaller, is set to showcase a significant CAGR of 1.3% through 2033 in terms of route of administration. Further, the retail pharmacies distribution channel is projected to expand at a CAGR of 1.4% by 2033.
| Segment | Value-based CAGR (2023 to 2033) |
|---|---|
| Oral (Route of Administration) | 1.3% |
| Cardiology (Indication) | 1.3% |
| Retail Pharmacies (Distribution Channel) | 1.4% |
| Anti-Diabetic (Drug Class) | 1.3% |
By drug class, the anti-diabetic segment generated a 13.2% share in Europe super generics business in 2022. Anti-diabetic drugs are gaining traction and have an impressive share due to the disease's growing prevalence in Europe. There is a high scope to deliver affordable medication to the population. However, the complexity of the disease puts affordability at bay.
The super generics demand in the treatment of diabetes can emphasize innovative formulations, such as alternative delivery systems or extended-release tablets. These formulations would help better control blood sugar levels and improve patient outcomes.
Developing super genetic drugs that combine diverse anti-diabetic drug classes into a solitary formulation can improve convenience and advance patient compliance core. In addition to traditional small molecule drugs, the expansion of biosimilar versions of biological anti-diabetic drugs is vital to care about. These biosimilars can provide more cost-effective substitutes to existing biological treatments for diabetes.
Tailoring anti-diabetic drugs to a patient's genetic or molecular profile could be a promising area in the metagenomic drug. This approach could lead to more operative and targeted treatments. Super generics companies in the diabetes space can integrate digital health technologies to improve patient compliance, monitor glucose levels in blood, and offer personalized treatment recommendations.
The cardiology indication segment was valued at USD 3.1 billion, representing a sizable 26.9% share in 2022. Cardiovascular disease (CVD) continues to be a prevalent health issue affecting both men and women across Europe.
Its impact extends beyond individual health concerns and carries significant societal implications. According to the World Heart Federation report in 2019, CVD death rates were higher in males than females in all countries in Central Europe and Eastern Europe, among others.
Cardiovascular super generics can emphasize innovative formulations, such as new drug delivery systems, combination therapies, and extended-release tablets. These designs aim to advance the management of cardiovascular diseases and improve patient outcomes.
Given the high pervasiveness of hypertension and the need for operative treatment possibilities, super generics in the cardiovascular can target this condition. These are capable of offering innovative formulations or combination therapies for improved blood pressure control, which would push demand.
Cardiovascular super generics can also aim to advance antiplatelet and anticoagulant therapies, providing improved options for patients with these conditions. The expansion of biosimilar drugs used in cardiology, such as PCSK9-targeting drugs for cholesterol management, is an important area of significant attention. These biosimilars can provide more cost-effective substitutes to prevailing biologic treatments.
Retail pharmacies hold a significant presence in the Europe super generics business, representing a 31.4% share of the total value in 2022. They are expected to demonstrate robust growth at an average CAGR of 1.4% throughout the forecast period.
Retail pharmacies offer a wide range of generic options, allowing consumers to save money on their healthcare expenses. Also, in several countries across Europe, pharmacists are authorized to substitute brand-name prescriptions with generic equivalents when available unless a healthcare provider specifies otherwise.
Retail pharmacies are set to be the primary access point for patients to get prescription drugs, including generic drugs. They play an essential role in ensuring that these goods are easily accessible to patients.
Retail pharmacists are often the first point of contact for patients looking for information about their medications. They can instruct patients about the benefits and latent differences between super generics and standard generics.
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The Europe super generics business has become intensely competitive, with multiple manufacturers vying for a high share. These players would actively engage in strategic initiatives to pursue a competitive advantage. Such initiatives include acquiring competitor firms and establishing collaborations with healthcare institutes to foster the development of innovative product lines.
The actions aim to strengthen their positions in this highly competitive landscape and deliver enhanced value to consumers. Companies are also implementing mergers, acquisitions, and collaborations in the conventional pharmaceutical sector to gain a more significant share.
For instance:
| Attribute | Details |
|---|---|
| Estimated Europe Super Generics Revenue (2023) | USD 11.6 billion |
| Projected Europe Super Generics Revenue (2033) | USD 14.2 billion |
| Value-based CAGR (2023 to 2033) | 2.0% |
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2018 to 2022 |
| Sales Analysis | Value (USD billion) |
| Key Regions Covered | Western Europe; Eastern Europe; and the rest of Europe |
| Key Countries Covered | Germany, France, Spain, Italy, BENELUX, Nordic Countries, United Kingdom, Poland, Hungary, Romania, Czech Republic |
| Key Segments Covered | Drug Class, Route of Administration, Indication, Distribution Channel, Region |
| Key Companies Profiled | AbbVie; Sun Pharmaceutical Industries Ltd.; Endo International; Viatris Inc.; Dr. Reddy's Laboratories Ltd.; Innovida Pharmaceutique; SERB Specialty Pharmaceuticals; Eagle Pharma; Novartis AG |
| Report Coverage | Sales Forecast, Competition Intelligence, Dynamics and Challenges, Strategic Growth Initiatives |
The Europe business was worth USD 11.4 billion in 2022.
The Europe business is estimated to reach USD 11.6 billion by 2023.
The business is set to reach USD 14.2 billion at a 2.0% CAGR by 2033.
The Europe business grew at a CAGR of 1.5% between 2018 and 2022.
The United Kingdom contributed USD 1.3 billion in 2022.
In Europe, Poland accounted for a value share of around 12.2% in 2022.
1. Executive Summary 2. Overview 3. Key Trends 4. Value-Added Insights 5. Background 6. Europe Demand (in Value or Size in USD billion) Analysis 2018 to 2022 and Forecast, 2023 to 2033 7. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Drug Class 7.1. Antihistamines 7.2. Antimicrotubule Agents 7.3. Aryl Acetic Acid Derivatives 7.4. Atypical Antipsychotics 7.5. Anti-Diabetic 7.6. Anti-Obesity Drugs 7.7. Calcium Channel Blockers 7.8. Corticosteroids 7.9. Fibric Acid Agents 7.10. GABA Analogs 7.11. Opioid Analgesics 7.12. Proton Pump Inhibitors 7.13. Retinoids 7.14. Others 8. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Route of Administration 8.1. Oral 8.2. Topical 8.3. Parenteral 8.4. Others 9. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Indication 9.1. Oncology 9.2. Cardiology 9.3. Diabetics 9.4. Neurology 9.4.1. Migraine 9.4.2. Epilepsy 9.4.3. Alzheimer 9.4.4. Pain Management 9.5. Gastroenterology 9.6. Dermatology 9.7. Analgesics & Anti-inflammatory 9.8. Weight Management 9.9. Ophthalmology 9.10. Others 10. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Distribution Channel 10.1. Hospital 10.2. Specialty Clinics 10.3. Retail Pharmacies 10.4. Drug Stores 10.5. Online Pharmacies/ Mail Order Pharmacies 11. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 12. United Kingdom Analysis 2018 to 2022 and Forecast 2023 to 2033 13. Germany Analysis 2018 to 2022 and Forecast 2023 to 2033 14. Spain Analysis 2018 to 2022 and Forecast 2023 to 2033 15. Italy Analysis 2018 to 2022 and Forecast 2023 to 2033 16. France Analysis 2018 to 2022 and Forecast 2023 to 2033 17. BENELUX Analysis 2018 to 2022 and Forecast 2023 to 2033 18. Nordics Analysis 2018 to 2022 and Forecast 2023 to 2033 19. Poland Analysis 2018 to 2022 and Forecast 2023 to 2033 20. Hungary Analysis 2018 to 2022 and Forecast 2023 to 2033 21. Romania Analysis 2018 to 2022 and Forecast 2023 to 2033 22. Czech Republic Analysis 2018 to 2022 and Forecast 2023 to 2033 23. Russia Analysis 2018 to 2022 and Forecast 2023 to 2033 24. Structure Analysis 25. Competition Analysis 25.1. Novartis AG 25.2. AbbVie 25.3. Sun Pharmaceutical Industries Ltd. 25.4. Endo International 25.5. Viatris Inc. 25.6. Dr. Reddy's Laboratories Ltd. 25.7. Innovida Pharmaceutique 25.8. SERB Specialty Pharmaceuticals 25.9. Eagle Pharma 26. Assumptions and Acronyms Used 27. Research Methodology
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Super Generics Industry Analysis in Europe
