company directory Contract Research Organizations Find your German partner 1 Summary In their constant strive for innovation, outsourcing has become essential for biopharmaceutical companies. Contract research organizations (CROs) are independent service providers that help biopharmaceutical companies manage their drug development process. With their expertise in preclinical and clinical R&D, CROs have become key enablers and strategic partners for the biopharmaceutical industry. Germany provides access to a vibrant and highly diversified contract research landscape. CROs deliver high-quality services along the drug development pathway and meet the exacting demands of drug developers – from end-to-end development to tailored contract research activities. HEALTH MADE IN GERMANY has compiled this directory to give you an overview of companies active in Germany’s CRO sector. The purpose of this directory is twofold: First, to provide an introduction to the country’s contract research landscape. And secondly, to help you to quickly find services of interest to your business. As such, the directory is an invaluable resource that also provides the tools necessary for you to take the next step – establishing contact with the appropriate partners in your area of activity. Content INTRODUCTION 5 Managing the drug development process 5 CROs as key players in pharma innovation 6 Growing and maturing CRO landscape 7 Different models of cooperation 7 Spectrum of services offered by CROs 7 Strengths of CROs in Germany 8 Drug discovery and preclinical studies 9 Clinical CRO landscape 10 COMPANY PROFILES 11 Company and technology overview 16 Company profiles 72 OUR PARTNERS Industry Associations 74 OUR SERVICES 75 CONTACT 75 IMPRINT 3 INTRODUCTION Contract research in Germany Outsourcing research has become essential for biopharmaceutical companies in their hunt for innovation. Contract research organizations (CROs) help them to manage their drug development process. With their expertise in preclinical and clinical R&D, CROs in Germany are key enablers and strategic partners in the complete drug development pathway. Contract research organizations (CROs) are laboratory services, other functions associated independent service providers in the drug with getting new drugs or devices to market. development process. They provide a range of services to pharmaceutical, biotechnol- There are more than a dozen global full-service ogy, and medical device companies as well CROs that offer the complete spectrum of serv- as governments, academic institutions, and ices needed for drug development. These larger other research entities. These services can CROs generally provide services to large pharma encompass all phases of the drug develop- companies. A growing number of smaller speci- ment life cycle – from compound selection, ality CROs provide tailored services that focus discovery, pre-clinical and clinical research on a particular stage of clinical development or to post-approval services including commer- offer defined services within a specific thera- Outsourcing cialization, safety assessment, monitoring, peutic niche – largely addressing smaller and has become and consulting. mid-sized pharma clients. This flexibility and a standard know-how is also becoming increasingly attrac- procedure in the Managing the drug development process tive for Big Pharma clients. Germany provides age of agile and Contract research organizations help biophar- access to a broad range of CROs in a vibrant and flexible pharma maceutical companies manage the drug devel- highly diversified contract research landscape development. opment process. Thanks to their expertise, they that covers all stages in drug development and are often able to do so more cost effectively value creation. and with a shorter time-to-market than in- house R&D departments. CROs fall into several CROs as key players in pharma innovation categories. Preclinical CROs test drug or device The innovation landscape of the global pharma candidates for client businesses before the com- industry has changed dramatically over the past pounds or devices undergo clinical or human decade. The whole industry – and Big Pharma in testing. This might include helping a client to particular – has experienced stricter regulatory synthesize compounds, run biochemical assays requirements, escalating commercialization costs or conduct animal studies. Clinical CROs focus and patent expirations on key blockbuster drugs. on clinical trial services such as medical writing, In order to increase drug-discovery program regulatory submissions, project management, success rates and reduce R&D costs, pharmaceu- monitoring, data management and analysis, tical companies seek to improve and accelerate The industry’s pipeline includes a diverse mix of new technologies Conventional therapies Other biologics Proteins and peptides Antibodies Cell and gene therapies Interventional phase 1–3 projects in thousands Compound annual growth rate 2015–2017 in percent 5 11 10 4 2 15 9 3 2 Share 2017 pipeline in percent 1 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 60 5 10 13 12 Original from McKinsey&Company (Source: PharmaProjects, 2017) 5 introduction for the biopharmaceutical industry. The current situation has evolved against the backdrop of an innovation landscape driven by exponen- tially growing biomedical information, powerful emerging technologies, and the increasing im- portance of interdisciplinary collaboration. These developments allow drug makers to cover a broader range of medical needs than in the past. The pharma pipeline has also diversified and is moving from one dominated by small molecules and monoclonal antibodies to a wide spectrum of new technologies and modalities. Examples of this include immuno-oncology moving from a niche interest to the mainstream, the dawn of cellular therapies, and the resurgence of gene therapies. Enhanced drug complexity brings with it an even higher complexity of associated clini- cal trials, requiring special planning, conducting and analyzing expertise. Growing and maturing CRO landscape every stage of the drug development process. The CRO industry has been growing steadily. It Pharmaceutical companies are increasingly turn- has benefited from recent downsizing trends in ing to agility and flexibility concepts in order to combination with growing R&D pipelines in Big reduce costs and speed up time-to-market for Pharma, as well as from a proliferation of small- novel therapeutic and diagnostic products. They er drug makers (Tufts CSDD 2019). Outsourcing are downsizing their in-house capacities and their R&D to CROs allows smaller or sometimes increasingly outsourcing their research activi- fully virtualized companies to manage drug ties to independent service providers. With the development programs with minimal infrastruc- advent of a maturing CRO industry, outsourcing ture. CRO market forecasts vary among differ- has become a standard procedure in pharma ent analysts. In 2018, the global CRO services R&D. As a result, CROs have become key players market was estimated to be worth USD 37 Global CRO market and penetration rates (In-house vs. Outsourced) in percent In-house (LHS) Outsourced (LHS) Global CRO development spending (RHS) 100% 45 Global CRO market in bn USD market CRO Global 40 75% 35 50% 30 25% 25 0% 20 2013 2014 2015 2016 2017 2018 2019 2020 Original: resultshealthcare.com (Source: Baird, 2015; CRO Industry Primer, Credit Suisse, 2016; 2017 CRO Market Size Projections 2016–2021, ISR Reports, 2017) 6 Contract Research Organizations | health-made-in-germany.com billion (Results Healthcare “CRO sector” 2019). CRO market size by activity The outsourcing penetration level is expected to in billion USD increase to 60 percent in 2020. Market research- ers predict that more than one third of all global Central Lab 2.0 (4%) Post-Approval 23.2 (45%) drug-discovery research will be outsourced to CROs by 2021 (Kalorama Information “Outsourc- Prelinical 4.8 (9%) ing in Drug Discovery” report 2018). Different models of cooperation The way biopharma companies work with CROs Clinical 22.0 (42%) has changed tremendously. Once driven by “tac- tical” or “functional outsourcing” considerations, the CRO industry now takes on a much larger and more complex role in pharma R&D. For the pharma client, CROs have become strategic de- Source: Credit Suisse (Company data, EvaluatePharma, Credit Suisse estimates) velopment and cooperation partners that base their business model on enabling technologies that guarantee higher quality and more efficient home to a strong network of specialized CROs R&D process execution. Nowadays, there are covering a broad range of services support- various models of collaboration between spon- ing drug developers to remain innovative and sors and CROs. These include the outsourcing of competitive, flexible and agile. The versatility functional teams (“resourcing”), asset transfer, and strength of the German CRO landscape is and risk sharing. It is clear that not only the a solid reference point for collaboration at the number of CROs has increased, but that they international level. have grown by accumulating knowledge and expertise beneficial to their clients. The majority of the 112 German contract research providers presented in this guide fall Spectrum of services offered by CROs into the category of small and medium-sized R&D tasks that biopharma companies choose to enterprises (SMEs). This directory of companies outsource include a wide spectrum of activities