The Pharmaceutical Sector

HEALTH MADE IN GERMANY The Pharmaceutical Sector

1 The Pharmaceutical sector Summary

Germany is a major actor in the global healthcare sector and boasts a leading industry that devel- ops, produces and distributes high-quality pharmaceutical products serving markets worldwide. The pharmaceutical sector benefits from cutting- edge research facilities, a long tradition in manufacturing and a highly diversified mix of large corporations as well as small and medium-sized enterprises (SMEs). Together, they form a strong base and provide the expertise necessary to meet the challenges of a changing global health market. This is best examplified by increasing pharmaceutical export volumes, especially in Asia and Latin America. Germany is also among the world’s top five pharmaceutical manufacturing services locations.

13% of annual revenues are invested in Research and Development

660+ pharmaceutical companies are situated in Germany

EUR 63.5 bn export sales generated by German pharmaceutical companies in 2016 594 clinical trials financed by pharmaceutical companies took place in Germany in 2016

2 The Pharmaceutical Sector | health-made-in-germany.com Market Data

Global demand for high-quality drugs is con- Total Sales of German Pharmaceutical Products in Foreign Markets stantly rising due to a growing global population, in EUR billion improved healthcare standards and strengthened economies in non-industrialized countries. Accord- ing to IMS Health, global spending on medicine 62.5 63.5 will reach USD 1.5 trillion by 2021. The sector is 55.3 largely driven by innovation, a fact best demon- 52.5 50.1 strated by the high numbers of newly approved drugs in Europe. More than 400 new pharmaceuti- 42.1 38.7 cal entities - on average 37 per year - have been authorized by the European Medicines Agency of the European Union since 2006.

The German pharmaceutical sector provides a broad range of high-quality products and services to address growing international demand. In 2016, German companies generated EUR 63.5 billion 2010 2011 2012 2013 2014 2015 2016 in export revenue. Today, international markets Source: destatis account for more than 66 percent of annual turnover in the German pharmaceutical sector. Between 2005 and 2016, export figures for German phar- Hamburg, Berlin, Cologne, Frankfurt (Main), and maceutical companies recorded an annual growth Munich. The German pharmaceutical sector is rate of around 10 percent. German pharmaceutical dominated by SMEs, with about 400 companies products are particularly sought after in the USA having fewer than 20 members of staff. and European countries. However, emerging markets, for example in Asia and Latin America, are Germany can look back on a long tradition as the also registering increased demand. “world’s pharmacy” and even today ranks among the world’s top five pharmaceutical production More than 660 pharmaceutical companies – of locations - being second only to the USA in terms German origin and subsidiaries of multinational of fermentation capacities. Major domestic phar- corporations – are based in Germany. These com- maceutical companies (including Bayer, BASF, panies employed a workforce of around 114,000 Boehringer Ingelheim, and Merck) and numerous in 2015 - mostly located around the cities of SMEs enjoy an excellent international reputation in all of the relevant pharmaceutical markets. This ranges from prescription to over-the-counter Export Volumes of the German Pharmaceutical (OTC) drugs, from original drugs to generics, from Industry small molecules to biopharmaceuticals. The sec- Export Sales in percent of Total Turnover tor also benefits from the internationally strong chemical companies that are domiciled in Ger- many, providing further manufacturing expertise 66.5 64.6 and infrastructure. 62.5

53.5 One of the industry’s key success factors is its 47.9 strong focus on research and development (R&D). Total R&D spending increased significantly to EUR 5.4 billion in 2015. This is equivalent to 13.2 percent of revenue, making it higher than in any other sector of industry in Germany. Most of the more than 300 drugs currently developed and set for approval in 2017 are targeting indications such as cancer (33 percent), inflammatory diseases (17 per- 2000 2005 2010 2015 2016 cent) and infectious diseases (12 percent). Source: destatis

3 Digital Health and Personalized medicine Industry Trends

High-quality Products for also to provide new drug applications, enhance International Markets the effectiveness of treatment, and empower A steady increase in the quality of healthcare patients to actively manage therapies. Most of across the globe, the establishment of health the large German corporations have founded spe- insurance systems in developing countries, and cial hubs and accelerators to build a platform for new hospital infrastructures have all led to a innovative IT-based healthcare solutions. growing global demand for conventional pharmaceutical products. German pharmaceutical Other aspects of digitalization include the intro- companies are best known to deliver high-quality duction of online and real-time monitoring in production volumes for many conventional pharmaceutical production plants, connected pharmaceutical products such as antibiotics, manufacturing processes, and increased automa- hormones, vitamins, and radiopaque materials. tion of industrial value chains in the sector. With This has allowed them to establish themselves its strong tradition of engineering and plant as attractive export partners for many countries construction and its expertise in pharmaceutical around the globe. The export revenues for Ger- chemistry, Germany offers the perfect infrastruc- man companies in Asia, for example, increased by ture for combining cost-efficient, IT-based innova- 15 percent in 2015, reaching almost USD 6.8 billion. tion with traditional high-quality manufacturing Here, the most attractive market is China, where, processes. For this reason, a wide variety of con- 22 percent of imported pharmaceutical products tract manufacturing service organizations (CMOs) originate from German companies. Herbal medi- have established themselves in Germany over the cines, original drugs and prescription drugs are in decades. This is particularly true for the biophar- particularly high demand. maceutical sector which has experienced strong growth in recent years. Digital Health for Better Patient Care Technology-driven developments such as digi- These CMOs profit from an ongoing outsourcing talization and Industry 4.0 are also revolution- trend, making Germany the number two location izing the pharmaceutical sector and healthcare worldwide in terms of fermentation capacities. management. This offers great potential for The country also has a strong network of con- more efficient research and development pro- tract research organizations (CROs) that provide cesses since computer-based, high-throughput services relevant to drug development (target approaches facilitate improved big data analyses. validation, lead optimization including delivery This increases the speed at which new therapies technologies, toxicological studies, bioanalytics and diagnostics go from lab to market. German and clinical trials management). The versatility pharmaceutical companies are increasingly aware and strength of the German CRO landscape, as it of new digital solutions and actively promote speeds up drug development, is a good reference cooperation with start-ups and smaller companies point for international collaboration. from the biotechnology, medical technology and IT sectors. The aim is not only to improve R&D but Personalized Medicine Focus Innovation in the pharmaceutical sector is largely driven by technological advances made in molecular and cell biology. New technologies DIGITAL HEALTH and research tools based on these findings pave the way for a better understanding of disorders A significant number of and permit new strategies for combating not

HEALTH MADE IN GERMANY companies in Germany only symptoms but actual causes. Personalized The Digital Health Sector are developing digital medicine has also emerged as a new trend for health solutions. This targeted therapies. Biotechnology has developed publication gives an as a major cornerstone in the development of new overview of the sector treatments in this context. German companies and provides partner have played a substantial role in bringing these links. approaches from lab to market and into clinical 1 practice. They can draw on a high level of expertise in clinically relevant biomarker R&D and a

4 The Pharmaceutical Sector | health-made-in-germany.com strong diagnostics sector which offers companion diagnostics (CDx) for use in personalized medicine. MEDICAL BIOTECHNOLOGY

Furthermore, German biotech companies are par- Medical Biotechnol-

ticularly renowned for their expertise and innova- HEALTH MADE IN GERMANY ogy is one of the most The Medical tion potential in targeted therapies for a broad Biotechnology Sector innovative healthcare range of indications from oncology to infectious, fields in Germany. This metabolic, neurological, and inflammatory dis- publication provides an eases. In recent years, domestic and international industry overview. pharmaceutical industry stakeholders have set up cooperation agreements and licensing deals with German biotech companies and start-ups to profit 1 from this experience.

This is particularly true when it comes to new therapies for the treatment of cancer patients. neurology (7 percent) and cardio-vascular dis- German pharmaceutical companies are at the eases (6 percent). German companies have exten- forefront of developing innovative approaches, sive experience in addressing specific groups of for example, in the field of immunotherapies. patients. Many of them, for instance, specialize in Advances in biomedical research in recent decades the development of therapies for children which have led to an increased understanding of the is still one of the major challenges of modern inner workings of the body’s defense system. medicine. New procedures based on bi- and multispecific antibodies, glycomodified antibodies, antibody- drug conjugates (ADCs), mRNA and DNA, oncolytic viruses, and cell therapies are well established in Germany. Based on this, many German companies are currently working on new preclinical and clinical drug candidates to fight cancer in a targeted manner (see “Spotlight on Oncology”).

High Level of Orphan Disease Expertise The advancement of knowledge in understand- German Export Volumes in Different Foreign Markets ing the molecular biology of diseases has also in EUR million become the basis for developing targeted therapies for niche indications and rare diseases. As demonstrated by European Medicines Agency USA 13,489 (EMA) and US Food and Drug Administration (FDA) statistics, the number of orphan drug des- Netherlands 8,216 ignations has increased significantly over the past years. Facilitated approval processes for these drugs have further strengthened this trend. These United Kingdom 7,100 favorable conditions have also paved the way for innovations developed by SMEs. According to the Switzerland 4,647 EMA, more than 70 percent of the medicines for rare disorders in the EU originate from the labo- France ratories of SMEs, and German companies with 3,663 their strong innovative capacities are increasingly active in this field. This is examplified by grow- Italy 2,621 ing approvals for orphan drugs in Germany. On average, one fifth of new drugs targeted orphan China 2,264 diseases, most of them for treatments in oncology (44 percent), metabolic diseases (21 percent), Source: BPI 2016

5 High Potential for cooperation Sector Structure

The German pharmaceutical sector is known for approved in Europe and newly developed drug its far-reaching competencies in a number of busi- candidates underline this high level of engagement. ness fields. This is reflected in the huge diversity A glance at the pipeline of biopharmaceutical com- of products and services offered. Companies panies active in the Association of Research-Based actively focus their activities on: Pharmaceutical Companies (vfa) demonstrates that these three disciplines alone account for more than • development, distribution and sale of original 470 new agents currently under development from prescription drugs such as small molecules and clinical phase I to III. A further analysis of vfa mem- biopharmaceuticals for the treatment of severe ber companies highlights that the majority of drug diseases projects with a chance of approval in 2017 focus in • manufacture, distribution and sale of generics particular on treatments for cancer (33 percent), and biosimilars inflammatory (17 percent) and infectious diseases • development and manufacture of over the coun- (12 percent). ter (OTC) drugs • phytotherapy and homeopathic products Generics Expertise • manufacture and/or contract research for Another major strength of the German pharma- national and international clients ceutical industry is its expertise in generics. This is reflected, among other things, in its activity on Many companies address several of these activ- the German market as demonstrated by recent ity areas at the same time to broaden their client statistics published by the German Medicines portfolio and to exploit synergies. Manufacturers’ Association (BAH) in 2017. The statutory health insurance companies in Germany Pharmaceutical Innovation to Combat paid a total of EUR 12 billion for generic products Common Diseases in 2016. Most of these drugs are produced by The German pharmaceutical industry is world German companies with a reputation for high- renowned for its commitment to innovation. This quality manufacturing processes. is reflected in high R&D spending levels, with companies able to provide extensive expertise in the This also holds true for the growing biosimilars treatment of numerous patient indications. Major market. Due to the expiry of patent protection activities relate to widespread common diseases, for many of the original biopharmaceutical drugs, such as in the fields of oncology, metabolic diseases generic companies and innovators are increasingly and immunology. The number of drugs already focusing on offering generic variants of biopharmaceuticals. With its considerable expertise in biopharmaceutical manufacturing, Germany pro- German Contract Manufacturing Company Services vides excellent infrastructure for the production in percent of biosimilars for the national and international market. From this perspective, due to a higher demand for cost-effectiveness in healthcare sys- Packaging Services 58 tems worldwide, German companies are also well- positioned in this area in the long term. According to the vfa, biosimilars accounted for 25 percent of Other Services 50 all phase III candidates in the entire biopharmaceutical pipeline of German pharmaceutical com- Solid Forms 29 panies in 2016.

Fluid Forms 21 High Quality Contract Manufacturing Around 11 percent of German pharmaceutical companies are active in the contract manufacturing 20 Specialized Forms business. More than 300 companies offer a wide range of products, such as packaging services (58 Custom-Made 9 percent), solid forms (29 percent), liquid forms (21 Products percent), specialized forms (20 percent), custom- Source: NIW, 2015 made products (9 percent) and other services (50

6 The Pharmaceutical Sector | health-made-in-germany.com percent). Most are located in North Rhine-West- Top Indications of OTC Products according to Turnover in Germany phalia, Baden-Württemberg and Bavaria. There in EUR million are three types of companies among the contract manufacturing organizations (CMOs): Cold Medicines and Drugs against Influenzal Infection 704 • traditional CMOs focusing only on this business activity General Pain Treatments 527 • pharmaceutical companies that have merged Muscle and Joint Pain 504 with a CMO, now offering these services among Treatments other areas of business • traditional pharmaceutical companies offering Antitussive Medicines 374 CMO services to operate at full capacity Gastrointestinal and Diges- 339 tive Treatments Within the highly competitive CMO markets, Ger- man companies are well-known for their high Mineral Nutrients 299 degree of specialization, vertical integration and Products for other flexibility, the high quality of their process opti- 280 Respiratory Diseases mization and employee education, and excellent linkages with the German chemical industry. Today, Abstergent Agents 249 these competencies are increasingly in demand because more than 80 percent of the innovation- Treatments against Skin Fungi 214 driven pharmaceutical companies outsource their production to external organizations, particularly Tranqualizers and 214 with regard to generic drugs. Sleep-Inducing Drugs

Source: BAH/IMS Health 2017 OTC Products Made in Germany Companies focusing on the development and distribution of over-the-counter (OTC) products are another expertise of the German pharmaceutical Drug Candidates of German Companies with a Chance of Approval industry. In Germany alone, pharmaceutical compa- in 2017 nies achieved segment turnover of EUR 6.7 billion. Cold medicines, general pain treatments and thera- Others 20% Cancer 33% pies to combat muscle and limb pain count among the core competencies of German enterprises in this field. A large proportion of the products are sold on the domestic market. According to the BAH, Mental Illnesses 5% this section of the industry contributed a gross value of around EUR 1.4 billion to the German econ- Diabetes Type 2 5% omy in 2015. A growing number of companies also Cardiovascular Diseases 8% offer special therapies such as phytotherapies and homeopathy. One third of OTC product turnover is already generated in this segment, with experts Infectious Diseases 12% Inflammatory Diseases 17% forecasting further growth in the future. Germany’s Source: vfa 2017 strong domestic market makes OTC manufacturers attractive business partners for international clients. Plant-based, high-grade medicines “Made in Germany,” for example, are among the top pharmaceutical products sold in Asian countries.

Company Directory: Herbal, Homeopathic & Anthroposophic Medicines www.health-made-in-germany.de

7 Focus on Innovation The Pharmaceutical Landscape in Germany

Innovation Leader Germany German Pharmaceutical Company R&D Expen- Germany offers the ideal infrastructure for the diture development and production of research-inten- in EUR billion sive, high-grade products. It places a great value on technology, backed by the country’s long his- tory in the pharmaceutical and chemical industry, 5.46 5.06 as well as its particular strength in producing complex products where containment and sterile 4.16 environments are critical. Hundreds of thousands 3.80 of highly skilled employees with backgrounds in medical technology, pharmaceutical technology, engineering, and processing make it possible for German pharmaceutical companies to set up and run high-quality processes.

R&D Excellence The German pharmaceutical sector also works 2000 2005 2010 2015 very closely with non-university research insti- Source: vfa, 2016 tutes, universities, hospitals, and start-ups from the biotechnology, medical technology and chemical fields. In industry clusters and net- is able to efficiently commercialize innovative works throughout the country they are aiming drugs. In 2016, the Federal Institute for Drugs and to improve existing treatments and develop new Medical Products (BfArM) approved more than therapies. Over the past decades, some regions 1,500 advancements of existing agents relating, have become established as Europe’s leading for example, to new indications or with improved R&D hubs and chemical parks, paving the way for delivery and formulation modes. interdisciplinary collaboration. German Centers for Health Research The German pharmaceutical industry, integrated The German government has consistently sup- into these networks as a valued partner, benefits ported excellence in health research. Since 2009, from the R&D excellence across the country and the German Federal Ministry of Research and Edu- cation (BMBF) and the federal states have phased in new research structures, known as the German German Pharmaceutical Industry Workforce Centers for Health Research, to more effectively Size address major common diseases such as cancer, diabetes, neurology, cardiovascular diseases, infectious diseases, and lung diseases. There are 112,475 114,069 currently more than 90 locations and 120 cutting- 103,208 105,435 110,006 110,036 edge research institutes that are part of this huge network. Many of them have launched several projects involving national and international pharmaceutical companies.

Strong Tradition in Infectious Diseases The development of new treatments for infectious diseases is a special area of German expertise. Based on major scientific developments made by German scientists such as Robert Koch and Emil Behring at the end of the 18th century, the devel- 2010 2011 2012 2013 2014 2015 opment and production of vaccines has estab- Source: BPI, 2016 lished itself as a core pharmaceutical competence

8 The Pharmaceutical Sector | health-made-in-germany.com in Germany. This rich legacy has led a number Number of Clinical Trials, Registered at German Regulatory Bodies of international corporations to construct large BfArM and PEI in 2016 facilities there in recent decades. Around 25 new industry-driven clinical studies with promising vac- cine candidates are established in Germany annu- USA 2,360 ally. Some German biotechnology companies, for instance, develop vaccination strategies based on Germany 594 natural messenger RNA as a data carrier instruct- ing the human body to produce its own proteins to fight a wide range of infectious diseases. Other United Kingdom 554 approaches have left the R&D phase and already entered the market: An innovative antiviral to treat Spain 499 human cytomegalovirus (HCMV) resulting from pioneering anti-infective research in a German bio- France 454 tech company reached the market in late 2017.

Germany also offers considerable expertise in the Italy 370 area of bacterial infections and the fight against multi-resistant pathogens. In the past two years, Japan 320 a growing number of German researchers have revealed new insights into promising antimicrobi- Belgium 303 als in high-level peer-review publications to fight antibiotic-resistant strains. Besides new antibiotics, the class of bacteriophages is identified as an Poland 292 alternative treatment option. In 2017, a substantial number of German clinical researchers at hos- China 290 pitals, academic institutes and pharmaceutical companies founded the “National Forum Phages” research forum at the University of Hohenheim Russia 215 (Stuttgart) to further explore this potential. This offers plenty of new collaboration opportunities India 39 with partners worldwide in the long term.

Source: vfa/ClinicalTrials.gov, 2017 Strength in Clinical Trials Germany also offers attractive conditions for conducting clinical trials. Geographically located at klinische Studien” (KKS - Coordination Centers for the heart of Europe and close to other European Clinical Studies) network to offer a one-stop-shop countries, Germany makes it easy to integrate and for companies and regulatory bodies. Germany’s manage study centers in the surrounding country attractiveness as a clinical trial location is con- markets and enjoys a reputation as a credible firmed by statistics available in the international clinical study location for realizing high-quality registry of ClinicalTrials.gov. According to an data. Growing numbers of clinical studies are analysis by vfa, a total of 594 trials financed by being conducted in German hospitals. The high pharmaceutical companies took place in Ger- level of expertise in clinical research is just one man hospitals in 2016. This puts Germany second reason why a number of German pharmaceuti- behind only the USA and ahead of other European cal companies have entered into major strategic countries such as the United Kingdom (554), Spain partnerships with German university hospitals to (499), and France (454). build up a new pipeline of promising new treatments. Around 20 university hospitals active in clinical research in Germany now work closely together within the “Koordinierungszentren für

9 Industry voices German Expertise

German pharmaceutical companies have extensive experience in bringing forward new drugs and therapies from lab to market. Whether it’s drug discovery, drug development or drug manufacturing in traditional markets or innovative areas, whether it’s large corporations or medium-sized companies, pharmaceutical products “Made in Germany” are highly appreciated all over the world. At the same time, international markets play an important role in the German pharmaceutical industry. Dr Markus Rudolph Here, the CEOs and Board members of three Ger- CEO, InfectoPharm Arzneimittel und Conislium man pharmaceutical companies report on what GmbH, Heppenheim makes their expertise so interesting for international partners and why global alliances and What do international investors and partners strategic partnerships are the key to successful appreciate most about your expertise? business development. InfectoPharm holds a leading market position in pediatrics. As well as around 30 outstanding prod- InfectoPharm strives to improve children’s health. ucts, we offer quick decision-making processes, Since 1988, the medium-sized company is focus- customized collaboration models, and a solution- ing on pharmaceuticals for children and difficult- oriented mindset. A highly qualified team aims to-treat infections. Today, InfectoPharm runs a to establish long-term cooperation and provides highly diverse portfolio of more than 100 products thorough scientific product training. Our pedi- and engages in about 30 strategic partnerships atric portfolio covers OTC and prescription-only globally. 180 employees contribute to the annual pharmaceuticals for indications such as infectious growth of this family-owned company. and respiratory diseases, dermatology, and gas- troenterology. The hospital anti-infective portfolio Boehringer Ingelheim is a research-driven, family- includes antibiotics for difficult-to-treat conditions owned large pharmaceutical company. Some like nosocomial infections and cystic fibrosis. 50,000 employees work in the three business areas of human pharmaceuticals, animal health What do you believe is the basis for successful and biopharmaceutical contract manufacturing. international cooperation and expansion? In 2016, Boehringer Ingelheim achieved net sales Dedication to the product and the task at hand of around EUR 15.9 billion. Research and develop- are crucial for any cooperation. Partners should ment expenditure runs at more than EUR 3 billion share a mutual understanding of the expectations annually – equivalent to around 20 percent of and challenges involved in international ventures company net sales. and respect each other’s decisions.

Desitin Arzneimittel GmbH is a medium-sized Which export markets and international pharmaceutical company. It operates internation- activities play a crucial role in your company ally, with subsidiaries in Germany, Switzerland, development? Scandinavia, and Eastern Europe. At its Hamburg Over the last five years, InfectoPharm has regis- plant it produces medicines for the treatment of tered mainly in Europe. We are now expanding neurological and psychiatric illnesses, offering a into non-EU markets and exploring future oppor- large number of established and innovative prod- tunities. Attractive target regions have large pedi- ucts, especially for its core indications of epilepsy atric populations and extensive needs for medical and Parkinson’s syndrome. solutions which counter the serious issue of resis- tance. We are seeking business partners who have a proven track record in the commercialization of healthcare products in these regions.

www.infectopharm.com

10 The Pharmaceutical Sector | health-made-in-germany.com Alan Hillgrove Dr Martin Zentgraf Member of the Board of Managing Directors with CEO, Desitin Arzneimittel GmbH, Hamburg responsibility for the Human Pharma Business Unit, Boehringer Ingelheim, Biberach What do international investors and partners appreciate most about your expertise? What do international investors and partners Our international business partners and licensors appreciate most about your expertise? highly appreciate our in-depth knowledge of the We are recognized by our business partners from German and international markets in terms of abroad for the high quality of our innovative prod- medical and scientific aspects of CNS in general ucts which we supply globally. Our international and market access specifically. Desitin has been customers value our experience, the service level committed to this therapeutic area for decades we offer and the clear solution orientation we and has extremely well-established customer rela- demonstrate. They benefit from our process excel- tions. lence, as well as the reliable and agile supply we guarantee. What do you believe is the basis for successful international cooperation and expansion? What do you believe is the basis for successful Our international expansion concentrates on the international cooperation and expansion? northern European territories and selected eastern We believe that cooperating and expanding busi- European countries. In most countries, the main ness on a global level can only be successful when focus of our activity is epilepsy. The development those endeavors are clearly embedded in the of new pharmaceutical dosage forms was essen- vision of the corporation. This allows us to suc- tial within the context of establishing the critical cessfully address all topics that arise and to put mass in the relevant markets. Further CNS innova- the needed resources behind these activities. The tions were added on this basis. success of an international cooperation requires strong partnerships, a clear understanding of joint Which export markets and international interests and objectives, as well as respect and activities play a crucial role in your company empathy for differences in culture and capabilities. development? The most important markets are those where Which export markets and international Desitin is represented with own subsidiaries – activities play a crucial role in your company such as Norway, Sweden, and Denmark, as well as development? the United Kingdom, and Switzerland. Our subsid- Our international activities are at the core of iaries in Eastern Europe – in the Czech Republic, everything we do. The global supply of our prod- Slovakia, and Romania – also play an important ucts at the high level of quality and service is only role. possible with a strong global network. Engaging in strategic international partnerships and further developing our company presence in the different countries allows us to be closer to our patients.

www.boehringer-ingelheim.com www.desitin.de

11 Special topic Spotlight on Cancer

High Medical Need for New Treatments Targeted Therapies for Personalized Cancer remains one of the major health threats Cancer Medicine in industrialized countries, being the second most German pharmaceutical and biotech firms con- frequent cause of death in Germany. Cancer treat- tinue to invest intensively in oncology research, ment is currently composed of five pillars: surgery, creating the basis for new personalized therapies. radiation, chemotherapy, targeted therapies and, They often pursue completely new approaches, most recently, immuno-oncological therapies. The such as bi- or multispecific antibodies, glycomodi- German pharmaceutical industry, including large fied antibodies, antibody-drug conjugates (ADCs), corporations and small and medium-sized compa- mRNA- and DNA-based approaches, oncolytic nies alike, has substantial activities in all of these viruses and cell therapies. They are not yet able five areas in joint collaboration with biotechnol- to overcome cancer but can help patients diag- ogy companies. nosed with cancer to live longer. Increasingly, cancer is becoming less a terminal illness and more Outstanding Research Infrastructure a chronic one, with German companies playing With its globally renowned research centers and a major role in further developing this trend. In excellent clinical infrastructure, Germany offers 2016, there were 226 active compounds in the outstanding opportunities for the research and German pipeline for biopharmaceuticals against development of new cancer drugs. The German cancer - far more than in any other research field. Cancer Research Center (DKFZ) in Heidelberg Every year, more than a dozen German companies ranks as one of the top locations worldwide in present their most recent results at the Annual the field. Meeting of the American Society of Clinical Oncol- ogy in Chicago. Understanding in oncology has increased significantly due to intensive research. This has helped For pharmaceutical companies, oncology is also to identify novel targets and biomarkers for the most interesting indication for conducting improving the efficacy of existing cancer thera- clinical trials in Germany. According to an analysis pies and diagnostics as well as bringing totally in the international trials register of ClinicalTrials. new drugs to the market. Since the 1980s, a total gov, pharmaceutical companies financed a total of of 29 biopharmaceuticals - three quarters of them 146 trials for testing cancer drugs in German clini- monoclonal antibodies - have been approved in cal research locations in 2016. Europe and Germany with a first indication for the treatment of cancer. They are now a firmly Expertise in Immunotherapies established part of modern cancer therapy. In Growing knowledge in immune biology and recent years, the sector has been particularly cancer research has enabled major advances, active with a total of ten new cancer drugs enter- particularly in immuno-oncology. German immu- ing the European and German markets in 2015/16. nologists and molecular biologists have uncov- ered a number of targets and signals within the Clinical Trials in Germany according to Indications Financed by the immune system that serve as keys for mobilizing Pharmaceutical Industry in 2016 the immune response in the fight against cancer cells. Checkpoint inhibitors are currently the most well-known approach used in several cancer indi- Oncology 146 cations. Large pharmaceutical corporations and small and medium-sized biotechnology companies Inflammatory based in Germany have excellent, long-estab- 142 Diseases lished expertise in developing novel immunotherapies that use different tools in the body’s own Cardiovascular 42 Diseases immune system to address cancer indications.

Infectious 30 Diseases

Diabetes Type 2 24 and its Effects Source: vfa/clinicaltrials.gov

12 The Pharmaceutical Sector | health-made-in-germany.com Actively helping to shape the digital transformation in the health care system. Five recommendations by the vfa for an innovation-friendly enabling policy

Our partners Industry Associations

The German pharmaceutical industry is repre- and partnerships with German companies active sented by a number of industry associations in the pharmaceutical sector. To further enhance that lobby for improvements for their member sector visibility, we facilitate the presence of Ger- companies. HEALTH MADE IN GERMANY works man players at relevant industry events and pro- closely together with them to provide support vide a platform for connecting with international for international companies seeking collaboration partners.

BPI – German Pharmaceutical Industry Association VfA – Association of Research-Based Founded in 1951 and thus with 65 years of experi- Pharmaceutical Companies ence in drug research, development, authoriza- The vfa, the Association of Research-Based Pharma- tion, manufacturing and marketing, BPI is the only ceutical Companies, is the trade organization of re- national trade association which represents the search based pharmaceutical companies in Germany. pharmaceutical industry with all its variety. Our Forty-three leading research-based pharmaceutical membership consists of 240 companies that cover companies are organized in the vfa. Together with classic pharmaceutical companies, businesses from their more than 100 subsidiaries and affiliated com- biotechnology, phytopharmacy and homeopathy panies, they employ nearly 76,000 people in Ger- as well as companies with a small generic port- many. The vfa member companies are among the folio. The majority of our membership are family leading research-based pharmaceutical companies owned businesses and small and medium-sized worldwide. They guarantee therapeutic progress enterprises that represent more than 11 percent of in pharmaceuticals and ensure high-quality phar- the pharmaceutical industry workforce in Europe. maceutical therapy. In Germany more than 16,000 As an association representing the whole section of their employees work in the field of research of the pharmaceutical industry BPI’s goal is to and development of pharmaceuticals. Here, the ensure that patients receive the care and medi- research-based pharmaceutical companies invest cines they need. BPI is a political partner for EUR 4 billion per year in pharmaceutical research. decision-makers which contributes to the ongoing The Association of Research-Based Pharmaceutical dialogue about the sustainability of healthcare Companies represents a German high-tech industry systems. that is competitive in the international markets.

www.bpi.de www.vfa.de/en

broadly represented medium-sized businesses. BAH covers the entire range of the industrial landscape from self-medication medicines (OTC) through to prescription drugs (Rx) and medical BAH – German Medicines Manufacturers’ devices. The association is a close contact partner Association for politicians, authorities and institutions within By company membership, the German Medicines the healthcare sector, and provides a strong link Manufacturers’Association (BAH) is the leading between various interest groups. trade organization of the pharmaceutical industry in Germany. It represents the interests of more BAH represents its members at European and than 450 member companies, which create about international level through the Brussels-based 80,000 jobs in Germany. Globally operating medi- AESGP and the Geneva-based WSMI. cines manufacturers are as involved in the mani- fold activities of the association as well as the www.bah-bonn.de/en

13 our services Health made in Germany

Germany is one of the world’s most important regulatory insight), introductory services, and providers and exporters of healthcare products networking platforms including trade events at and services. The country’s innovative medical home and abroad. The initiative serves four major products set international standards for quality, industries active in the international medical mar- safety and reliability. German manufacturers and ket: pharmaceuticals, medical technology, medical service providers in all health and life sciences biotechnology, and digital health care. segments attract overseas customers and partners and deliver leadership in healthcare innovation. HEALTH MADE IN GERMANY also works closely with 16 major German industry associations and HEALTH MADE IN GERMANY is the export initiative is part of the BMWi’s MITTELSTAND GLOBAL for the German healthcare industry. It supports umbrella program for small and medium-sized international companies and organizations that are enterprises. The initiative is ideally placed to interested in establishing contact with potential provide access to German healthcare market German partners and suppliers. Set up by the information and to help overseas businesses German Federal Ministry for Economic Affairs identify potential German partners. and Energy (BMWi), the initiative bundles expert market intelligence for easy industry access. One The HEALTH MADE IN GERMANY initiative is of the initiative’s main goals is to promote the implemented by Germany Trade & Invest, the German healthcare sector through international economic development agency of the Federal networking activities for the mutual benefit of Republic of Germany, on behalf of the BMWi. international partners and German companies alike.

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14 The Pharmaceutical Sector | health-made-in-germany.com CONTACT Expert Advice Imprint

Publisher Germany Trade and Invest Gesellschaft für Außenwirtschaft und Standortmarketing mbH Friedrichstraße 60 10117 Berlin Germany

Executive Board Dr. Jürgen Friedrich, Chairman/CEO Dr. Robert Hermann, CEO

Editor William MacDougall, Germany Trade & Invest, Berlin

Axel Lohse is the manager responsible for the Author medical biotechnology and pharmaceutical indus- BIOCOM AG, Berlin tries at HEALTH MADE IN GERMANY. He is your point of contact for expert advice in those fields Layout and looks forward to receiving your inquiries and BIOCOM AG, Berlin requests. Print Get in touch with us to learn more about what Kern GmbH, 66450 Bexbach HEALTH MADE IN GERMANY can do for you. www.kerndruck.de

Axel Lohse Notes Manager, Medical Biotechnology and All rights reserved. Pharmaceuticals ©Germany Trade & Invest, March 2018 Reproduction, in whole or in part, only permissible T +49 30 200 099-254 with express prior authorization. All market data [email protected] provided is based on the most current market www.health-made-in-germany.com information available at the time of publication. www.gtai.com Germany Trade & Invest accepts no liability for the actuality, accuracy, or completeness of the information provided.

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Picture Credits Front page: zorazhuang/istockphoto.com; page 10: Infectopharm; page 11: Boehringer Ingelheim, BPI; page 15: Illing & Vossbeck Fotografie

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