June2026 Objectives and approach Background •While the European biotechnology industry has been growing, there are concernsabout European competitiveness and whether Europe is lagging behind other globalregions in terms of investment, manufacturing, and commercialization•European pharmaceutical firms face structural barriers affecting investment decisions PolicyContext •What are key decision points faced by biopharmaceutical companies (and particularlyby smaller companies)?•How does Europe’s current policy environment compare to that of the US and China? Key ResearchQuestions Five identified key investment decision points This report presents an ‘overall’ visualisation aggregating metrics across the five categories. To develop this visualisation, for each of these five categories, we: 1.Set outthe policy context2.Describe theperspective of large and small firms3.Identifytwo easy-to-understand metrics4.Assessthe metrics acrossEurope, US, and China Note: Large firms tend to be established, multinational enterprises.Small firms are not limited to the EU’s legal definition of small andmedium enterprises (under 250 employees); in this report, they are Metrics for evaluation Foundations forSuccess EvidenceDevelopment Foundations for success Policy context:foundationsfor success Change in share of biotechnology patent filings, 2001to 20201: •Europe lags behind the US andis losing ground to China in the •While Europe has a strongscientific research andpublication base, it hasdifficulties in translating that •Access to financial support forstart-ups to scale up in Europetrails the US and China.2 •From 2020, 66 out of 67 EUbiotech companies that wentpublic did so by listing outside Considerations by company size: foundations for success Considerations Affecting All Companies •European biotech companies report public R&D underinvestment,indicating poor alignment across policies and programs and a lack ofpublic capital1,2 TotalConsideration Additional Burden for Smaller Companies •Smaller companies rely on VC funding. The traditional VC investmentcycle may not be suited to the long horizon of pharmaceutical R&D andcommercialisation2•Early-stage companies in particular face difficulties as investors prioritise Relevant metrics:foundationsfor success •Venture capital fundingplays a pivotal role in enabling biotech startups to pursueinnovative and risky products where traditional loans are unavailable1•In one study, approximately one-third of biotech companies reported that their currentfunding came from venture capital2 Availabilityof biotechventure •Pharmaceutical R&D is risky and costly, and patent protections act as a mechanism tosafeguard and incentivize innovation4 Strength ofintellectualpropertyprotections •Increased strength of patent rights strongly and positively affect R&D expenditure andforeign direct investment.5Regulatory incentives that extend patent life can have the •The strength ofintellectual property rights is closely correlated with the number of clinicaltrial starts in a country. Early-phase and innovative biologic clinical trials in particular are Availability of biotech VC funding andstrength of IPsystem, Europe pre-Biotech Act European biotech companies receive a smallfraction ofglobalbiotech VC funding.While IP protections are historically well-reviewed, recent legislation has weakened protections for Chinese biotechcompanies receive asmall fraction of globalbiotech VC funding.While IP protectionshave been strengthened,enforcement remains aconcern. US biotech companiesreceive the majority ofglobal biotech VCfunding, and the US’sstrength of the IP system Availability of biotech VC funding and strength of IPsystem, Europe post-Biotech Act The Biotech Act increases private and public funding, but theamount will vary depending on the success of implementation. Investment in evidence Policy context: investment in evidence development Change in share of commercially sponsored clinicaltrial starts, 2013 to 20231: •Europe faces barriers inclinical development and •These include conflictingapplication requirements,bureaucratic and technicalissues with submissions, andoverall increased burden onclinical trial applicants•Despite proposed legislation,regulatory fragmentationwithin the EU remains andposes barriers to clinical trialefficiency. There are alsoissues related to clinical trialcosts and wait times forauthorisation2 Considerations by company size: evidence development Considerations Affecting All Companies •Slow and complex regulatory frameworks lead to long and uncertainauthorisation processes, hindering innovation1 TotalConsideration Additional Burden for Smaller Companies •Smaller companies report longer clinical trial timelines, which oftencorrespond to increased monetary costs, than large companies2•Smaller companies often lack internal experience in clinical developmentand limited infrastructure, compounding time and money costs3•Biotech firms