Germany Biosimilars Market Research Report, 2030

Biosimilars are biological drugs that are extremely similar to a reference drug, a biological drug that has already received approval. They are designed to be equally safe and effective as the reference drug. The European Medicines Agency (EMA), which establishes standards for their research and approval, oversees the approval of biosimilars in Germany. With additional criteria to prove comparability with the reference biologic, the approval procedure for biosimilars in Germany is identical to that for biologics. Since 2006, biosimilars have been accessible in Germany, where they have one of the largest markets on the continent. The Drug Commission of the German Medical Association has developed guidelines for the therapeutic use of these biosimilars. In Germany, the prices of biosimilars are significantly lower than in other developed countries, and the nation has successfully fostered acceptance among payers, providers, and patients. Pharmacies can substitute a reference medication with its biosimilar or between different biosimilars. However, there are exceptions, this substitution may not occur if a physician specifically rules it out or if the pharmacy considers individual patient factors. Germany aims to further increase the uptake of biosimilars, and its companies are at the forefront of this field due to strong traditions in pharmaceuticals and chemical engineering. The introduction of the GSAV law in 2019 empowered the Federal Joint Committee (G-BA) to designate biosimilars as interchangeable, facilitating automatic substitution at the pharmacy level. This legislative move not only streamlined the approval process but also enhanced the accessibility of biosimilars to patients, thereby fostering greater market penetration. According to the research report, “Germany Biosimilars Market Research Report, 2030” published by Actual Market Research, the Germany Biosimilars market is projected to grow with 16.52% CAGR by 2025-30. The demand for biosimilars is being driven by the rising prevalence of chronic diseases in Germany, including cancer, diabetes, and autoimmune disorders. Because they are less expensive than biologics, biosimilars are a desirable choice for patients, doctors, and healthcare payers looking for affordable medicines. The cost reductions that biosimilars provide in comparison to reference biologics are one of the major factors driving the market for them in Germany. Biosimilars are an appealing choice for healthcare payers looking to save costs since they are often less expensive than the reference biologics they are based on. The emergence of biosimilars has additionally aided in boosting market competition for biologics, which may result in cheaper costs for patients. It is anticipated that the German biosimilar business would expand as additional biologics lose their patent protection and as physician and patient knowledge rise. Several key factors are driving the biosimilar market in Germany. Biosimilars are authorized copies of biologic drugs and are typically 20–25% less expensive. This cost advantage arises from fewer clinical trials, the absence of marketing or post-marketing research and development costs, and advancements in genetic engineering. The expiration of patents for high-revenue biologic drugs is a significant catalyst for the biosimilar industry in Germany. Additionally, rising healthcare costs are encouraging patients to choose biosimilars. Government organizations are also implementing policies to incentivize the prescription of these alternatives.

What's Inside a Actual Market Research`s industry report?

Asia-Pacific dominates the market and is the largest and fastest-growing market in the animal growth promoters industry globally

Download Sample

Biosimilars are now available on the market as a result of the patents on numerous biologics in Germany expiring. The use of biosimilars to lower healthcare costs has been aggressively encouraged by the German government, which has contributed to the expansion of the biosimilar industry. The European Medicines Agency (EMA) is in charge of biosimilar regulations in Germany, which are identical to those that apply to reference biologics. Biosimilars must, according to the EMA, show that they are comparable to the reference biologic in terms of quality, safety, and effectiveness. To prove their resemblance to the reference biologic, biosimilars must go through a rigorous clinical development program that includes comparison studies. Because part of the data may be inferred from the reference biologic, the approval procedure for biosimilars in Germany is often quicker than that for reference biologics. Due to the intricacy of the manufacturing process and the requirement to show comparability, the approval procedure might yet take many years. The G-BA (Gemeinsamer Bundesausschuss), the joint committee of the Federal Joint Committee (G-BA), oversees reimbursement for biosimilars in Germany. The G-BA is in charge of deciding whether medical goods and services are reimbursed in Germany. The same regulations governing reference biologic reimbursement apply to biosimilars, and their reimbursement rate is determined by the cost of the reference biologic. To lower healthcare costs, the German healthcare system has been actively encouraging the use of biosimilars. In addition to being less expensive than reference biologics, biosimilars also face price rivalry from other producers, which may result in additional price drops. The Germany Biosimilar Contract Manufacturing Market is witnessing significant growth driven by advancements in biotechnology and increasing demand for affordable biologic therapies. Within this broad market, the Product segment plays a crucial role, particularly with regards to Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins. Recombinant Non-glycosylated Proteins have gained prominence due to their applications in therapeutic areas such as endocrine disorders and cancer treatment, offering cost-effective alternatives to traditional biologics. As such, they are becoming a preferred choice among manufacturers who seek to reduce production costs while maintaining efficacy. Conversely, Recombinant Glycosylated Proteins are essential for their functional roles in therapeutics, especially in addressing complex diseases that require protein modifications for activity. These proteins are often utilized in products that necessitate a specific glycosylation pattern, which is critical for the stability and efficacy of therapeutic agents. The demand for these proteins is particularly significant given Germany's robust pharmaceutical landscape, bolstered by well-established regulatory frameworks and a strong focus on Research and Development. The advancements in biosimilar technology and the increasing acceptance of biosimilars in the therapeutic domain indicate a ripe environment for continued growth, reinforcing the importance of these segments in contributing to Germany's position as a leader in biopharmaceutical manufacturing. Monoclonal antibodies (mAbs) are leading the biosimilars industry in Germany due to their pivotal role in treating a wide range of complex, high-cost conditions and the country's well-established healthcare infrastructure that supports their use. These biologics are crucial in managing chronic and life-threatening diseases such as cancer, rheumatoid arthritis, and inflammatory bowel disease areas where Germany has witnessed a consistent rise in patient numbers. As original mAbs are often prohibitively expensive, biosimilar versions offer a cost-effective alternative without compromising on safety or efficacy, making them attractive to both healthcare providers and payers. Germany’s statutory health insurance system strongly supports the integration of biosimilars as a means to control costs while expanding access to advanced therapies. Moreover, the expiration of patents for several blockbuster mAbs like rituximab, trastuzumab, and adalimumab has opened the floodgates for biosimilar entries. Germany’s regulatory environment, particularly since the introduction of the GSAV law in 2019, has facilitated the substitution and prescription of biosimilars, significantly increasing their uptake. This legal and structural support has created a favorable climate for biosimilar mAbs to thrive. Additionally, German physicians are increasingly familiar and comfortable with prescribing biosimilars due to continuous education, real-world evidence, and guidance from professional associations. The high level of trust in the German regulatory and pharmacovigilance systems also plays a key role in the adoption of biosimilar monoclonal antibodies.

Make this report your own

We're excited to discuss your needs and our solutions. Let's schedule a call.

Ask an Expert

Nikita Jabrela

Business Development Manager

Oncology is leading the biosimilars industry in Germany primarily due to the high prevalence and rising incidence of cancer coupled with the substantial costs associated with biologic cancer therapies. Cancer remains one of the major public health challenges in Germany, with millions of patients requiring effective and sustained treatment regimens. Many of the original biologic drugs used in oncology, such as monoclonal antibodies targeting HER2, VEGF, or CD20, are not only highly effective but also extremely expensive, putting significant pressure on healthcare budgets. Biosimilars offer a vital solution by providing therapeutically equivalent alternatives at substantially lower costs, thereby improving patient access to life-saving treatments. Germany’s healthcare system, which emphasizes both high-quality care and cost containment, has actively promoted the use of biosimilars in oncology through favorable reimbursement policies and physician incentives. The GSAV legislation, which facilitates interchangeability and automatic substitution of biosimilars, has further accelerated their uptake in oncology practice. Moreover, oncologists in Germany have become more confident in prescribing biosimilars due to accumulating clinical evidence demonstrating their safety and efficacy, along with endorsements from medical societies and regulatory agencies. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

Don’t pay for what you don’t need. Save 30%

Customise your report by selecting specific countries or regions

Specify Scope Now

By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.