The life sciences industry has seen tremendous growth and transformation over the past decade. Advancements in technology, changing regulations and business strategies have paved the way for the emergence of a new sector - Life Sciences Business Process Outsourcing (BPO).
Introduction to Life Sciences BPO
Life Sciences BPO can be defined as outsourcing non-core business functions related to research, development, manufacturing and commercialization of pharmaceutical, biotechnology and medical device products. This relatively new sector focuses on providing specialized services and expertise to life sciences companies through contract partners. Some of the key functions outsourced include clinical data management, medical writing, regulatory affairs management, pharmacovigilance and financial services.
The growth of Life Sciences BPO can be attributed to several factors. Increasing R&D costs have compelled life sciences companies to focus internal resources only on core competencies. Stringent regulatory policies introduced in the post-2008 period also increased compliance burden on these companies. At the same time, emergence of specialized BPO vendors with therapeutic and regulatory domain expertise addressed the need for high quality services.
Market Analysis and Projections
As per recent reports, the global Life Sciences BPO market was valued at $21 billion in 2020 and is projected to grow at a CAGR of 11% between 2021-2026. North America currently dominates with over 45% market share owing to presence of many pharmaceutical giants and favorable government policies for outsourcing. Asia-Pacific region is expected to be the fastest growing market driven by low costs and increasing investments from multinational companies in countries like India and China.
Key Outsourced Functions
Clinical Data Management
Clinical data management involves collection, integration and validation of data generated during clinical trials of drug candidates. Outsourcing of these services helps life sciences companies access advanced technologies, statistical expertise and trained data managers.
Medical Writing and Publishing
Medical writing support is provided for regulatory dossiers, clinical study reports, scientific articles, patient education materials and more. It ensures adherence to target journal guidelines and compliance with global publishing standards.
Regulatory Affairs Management
External experts help with preparation of regulatory submissions for new drug/device approval, ongoing license maintenance and compliance with post-marketing regulations. This reduces internal resource burden.
Pharmacovigilance
Outsourced pharmacovigilance systems enable round-the-clock surveillance, aggregation and reporting of adverse drug reactions to global regulatory agencies. It is a critical post-marketing function.
Financial Planning and Analysis
BPO vendors provide cost analysis, budgeting, accounting and reporting services to support strategic decision making of life sciences companies.
Advantages of Outsourcing
Cost Reduction
BPO model results in significant savings on infrastructure, employee and compliance costs for life sciences companies. It offers an opex-focused operational model rather than capex.
Access to Quality Talent
Outsourcing partners can recruit and train dedicated staff with specialized therapeutic expertise not easily available in-house. This improves quality of deliverables.
Regulatory Compliance
BPO vendors make large investments to build robust systems and acquire latest certifications to meet stringent regulatory guidelines of FDA, EMA and other agencies.
Focus on Core Activities
Outsourcing non-core operations allows internal teams at biopharma companies to dedicate maximum time and resources towards innovation, clinical trials and new product launches.
Risk Mitigation
Using reliable, long-term outsourcing partners with business continuity plans can safeguard operations from potential disruptions and reduce compliance penalties.
Future Prospects
The growth trajectory of the Life Sciences BPO sector is expected to continue in the coming years. Industry experts anticipate increased outsourcing of new complex services like artificial intelligence-based drug discovery, real world evidence generation and advanced data analytics. Asia is emerging as a top investment destination with countries like India rapidly developing world-class infrastructure and workforce for this sector. Overall, outsourcing promises to transform the operating models of life sciences industry globally and deliver significant benefits to patients.
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