Life Sciences

Challenges & Trends
Key services
Solutions

Healthcare and life sciences organizations are operating in a highly regulated environment, with changing business models, disruptive technologies, and significant amounts of data. In addition, they need to demonstrate value from therapies, while considering the impact and importance of Environment, Social, and Governance (ESG) regulation and strategy. Meanwhile, technology giants are moving into healthcare at a growing pace. COVID-19 has accelerated many of these trends and placed unprecedented pressure on areas such as vaccine development.

In a rapidly changing world, our forward-thinking professionals focus on the horizon as well as the here and now, anchoring our experience in today’s reality while assisting healthcare and life sciences organizations to innovate and position themselves for tomorrow’s world. Our services are tailored to the issues that the industry and your organization experience.

We serve (bio)pharmaceutical, MedTech, BioTech and Life Sciences service companies. We have a core team of over 60 Life Sciences specialists in Belgium across Audit, Tax & Legal, and Advisory - with deep experience across the sector - who continuously strive to keep abreast of industry trends, drivers, and issues through knowledge sharing and industry insights programs. We have already helped many companies with the challenges of change management, ESG strategy and compliance, go-to-market strategy, funding and implementations, supply chain transformation, and mergers and alliances, to name a few.

Additionally, we work closely together with our global network of over 4,500 Life Sciences professionals, who have supported all of the top 25 Life Sciences organizations globally.

Challenges & trends

Shifts within the R&D ecosystem

Shifts within the Research & Development (R&D) ecosystem are driven by eroding margins and the pressure to de-risk R&D, the move towards personalized solutions, the shift from treatment to prevention as well as cure, and the wealth of new scientific and technological innovations.

Rapidly Changing Tax environment

International developments like the introduction of the global minimum tax may have a substantial impact on the group effective tax rate and will add an additional layer of complexity to tax compliance obligations. This changing environment drives life sciences groups to reconsider existing tax policies and take appropriate actions to safeguard an efficient and responsible tax setup.

Significant disruptions within the Supply Chain

The future of the supply chain in the Life Sciences sector is being disrupted to fit new business models, technologies and regulatory shifts. Companies will see significant disruptions as they shift towards customer-centric offerings with demand driven, automated networks underpinned by digital platforms and technologies.

Focus on personalized and patient centric solutions

The focus on niche patient pools and specialty disease drugs continues to increase while personalized and precision medicine is a reality. This impacts business models and how to operate across the value chain.

Complex regulatory requirements and compliance rules

The Life Sciences industry faces an ever-changing regulatory environment. Balancing the desire to innovate and to achieve business goals while being compliant and mitigating compliance risks are some of the most challenging tasks.

Disruptive technological innovations

The adoption of disruptive digital technologies to automate and to optimize the potential of data is critical given the pressure to look for performance and cost reduction opportunities. On the other hand, technology players enter the Healthcare space at a growing pace.

The importance of ESG goals

Long-term sustainability has recently become part of everyone’s agenda, but expertise is crucial. Regulations like the EU’s Corporate Sustainability Reporting Directive (CSRD) comes with its own implications and challenges for the Life Sciences industry. Key trends gaining saliency within this industry include diversity, equity and inclusion, access to medicine, pandemics, decarbonization, biodiversity, water management, and circular economy.

Key services in the Life Sciences sector

We have a core team of Life Sciences specialists in Belgium across Audit, Tax & Legal and Advisory. We are strongly connected within Belgium and internationally, sharing regular insights on trends, drivers and key issues.

KPMG supports Life Sciences companies on their transformation journey, leveraging data and analytics for better decisions and agile operations. Services include finance transformation, improving financial performance, guiding through procurement and supply chain challenges, implementing enterprise-wide solutions, and establishing cybersecurity strategies.

We support Biotech companies along their growth journey, understanding evolving needs and fostering agility. Through a strategic alliance with Brussels South Charleroi BioPark, KPMG reinforces Wallonia and Belgium’s position as a major European biomanufacturing hub.

Transformation & restructuring

Our team of experts assists Life Sciences companies in applying various existing incentives, including R&D tax incentives, in a combined, coherent, and sustainable manner. These incentives can significantly impact the company's overall financial position. Given the strict and formalistic approach taken by tax authorities when auditing (R&D) tax incentives, successful application depends on robust and coherent documentation, which our specialists can prepare.

Our Grants & Incentives Practice assists Life Sciences companies in securing funding for R&D, sustainable investments, and business transformation.

Tax & Legal

When it comes to defining an IP strategy, the tax implications of certain decisions should be carefully considered, aligned with business operations, and supported by a robust governance model. The registration of intellectual property is also of key importance for access to certain tax incentives, including the choice of IP protection.

Our team can assist you with the setup of an appropriate and sustainable transfer pricing policy, which is aligned with both the strategic objectives of the group and the operational reality of the business model from a global perspective. Our team also has valuable experience in obtaining advance tax rulings to provide upfront certainty on the application and amount of tax incentives applied, as well as Advance Pricing Arrangements (APAs) for cross-border certainty on transfer pricing policies on key controlled transactions.

Product development

We guide our Life Sciences clients through the ESG lifecycle: strategy design, operational systems setup, and non-financial reporting. ESG is pivotal for investors, customers, and regulators. Our team integrates sustainability into business strategy, leveraging specific expertise and experience tailored to the unique and diverse needs of the sector.

Sustainability analysis

Life Sciences companies work with a variety of third-parties such as CRO’s, CDMO’s, distributors, advisors, and many more. Without a holistic, technology-enabled oversight program on third-parties, those relationships can become a weak link. We support companies in understanding the organizational risks presented by third-parties, assess whether they can effectively manage those risks as needed, and establish consistent third-party oversight and monitoring.

Technology

Our assurance team has the knowledge, experience, and skills to perform internal audits and SOX engagements. We can help your organization meet rising expectations for operational efficiency and effectiveness - addressing related risks and internal controls. Our services provide assurance on process effectiveness and include actionable recommendations to enhance performance and strengthen control. As a strategic business partner, we enhance the relevance, value, and future-readiness of your internal audit functions. Additionally, we assist organizations in implementing and maintaining sustainable SOX 404 compliance programs through readiness assessments, documentation and testing support, and framework maturity evaluations. Our services cover country-specific SOX requirements, including US SOX, Korea SOX, and Japan SOX.

KPMG takes a risk-based approach to identify existing or needed internal controls over financial reporting (ICFR), addressing key financial reporting risks. This supports the implementation of your chosen control framework, such as COSO.

We support life science organizations in establishing and enhancing their risk management frameworks, including business continuity and crisis management, governance, business processes, and controls. Our goal is to provide confidence that risks and opportunities are managed effectively and align with decision-makers' expectations.

Our teams bring integrated, multidisciplinary, and cross-functional expertise to help you set up, improve, and execute internal audits, enterprise risk management programs, and risk and control management.

The search for next generation therapies, coupled with declining R&D returns, means companies seek to acquire innovation through external deals. At KPMG, we support valuation exercises and M&A transactions, and we have developed in-depth integration and carve-out expertise over the years within the Life Sciences industry.

We specialize in assisting clients with commercial strategy development, guiding go-to-market decisions, and crafting effective launch strategies. Our insights enable clients to support successful launches and drive product uptake. Leveraging expertise in quality of care, we collaborate with clients and opinion leaders to design transformative programs aimed at enhancing patient outcomes across various therapy areas and regions.

To make the difference, the auditor’s judgments must be rooted in an in-depth understanding of each client’s industry value drivers, competitive positioning, and marketplace practice. Our audit teams have the knowledge, experience, and skills in the Life Sciences sector to go beyond audit and provide relevant insights to bring your finance team to the next level.

We advise Life Sciences clients on a broad spectrum of issues as well as through the following integrated solutions

We believe the future enterprise will be Connected. Powered. Trusted. Elevated. Connected. Powered. Trusted. Elevate. is our definition of a digitally transformed organization. One that is connected, aligned, and engineered around the customer. One that is powered by modern technology and agile business practices. One that is trusted by all its stakeholders, from customers, employees and suppliers to investors and regulators. One that can elevate and is empowered to prioritize and deliver value confidently.

Connected

KPMG Connected Enterprise is our framework and approach for enabling customer-centric, end-to-end digital transformation that meets the wide variety of challenges the Biopharmaceutical, MedTech, Biotech Industry and pharmaceutical service companies are facing. A future-ready, connected Life Sciences company will have the capabilities to quickly respond to new data and market signals. KPMG Connected Enterprise focuses every critical process, function, and relationship of a business on meeting customer expectations, creating business value and driving sustainable growth in a digital world. KPMG Connected Enterprise for Life Sciences is an insight-led, customer-centric, enterprise-wide approach to digital transformation.

Powered

KPMG Powered Enterprise is an outcome driven, functional transformation solution that combines deep business & industry knowledge, global & local delivery capability, and the market leading cloud technologies. It helps drive sustainable change, rising performance and lasting value for your business, delivering on the business strategy. It is an integrated, market-leading solution that transforms business functions including Marketing, Sales & Service, Commerce, Supply Chain Management, Procurement, Finance, Human Resources, Information Technology, Enterprise Service Management, Cyber and Risk.

Trusted

The Trusted imperative embraces and represents the entire estate of KPMG firms’ capabilities in cybersecurity, risk, and regulation. It also asserts an enabling, multiplying role for Trusted thinking in digital acceleration and transformation. We believe trust is the ultimate business enabler: growth, performance, efficiency, and innovation are all fueled and facilitated by the confidence that people have in an enterprise.

Elevate

KPMG Elevate identifies and quantifies value-creation opportunities. We help businesses target and capture value using a data-driven approach – confidently helping to achieve measurable improvements to increase profitability and performance. We focus on what needs to change for an organization to become a successful, modern, high-performing business.