Consulting Demand Driven by Indian Companies

Industry estimates suggest that:

• 35–40% of EU regulatory consulting demand originates from non-EU companies

• Indian companies account for 20–25% of this non-EU demand, particularly in generics, APIs, biosimilars, and medical devices

This translates into a directly addressable consulting opportunity of approximately USD 300–380 million per year, growing at 8–10% CAGR—with growth further accelerated by the India–EU trade agreement.

When expanded to include clinical strategy, market access, HEOR, and medical device consulting, the total opportunity becomes significantly larger.

How the India–EU Trade Deal Changes the Equation

The India–EU FTA does not dilute regulatory standards. Instead, it materially improves the economic and strategic rationale for Indian companies to pursue EU approvals.

Key implications include:

• Improved trade economics and reduced tariff barriers

• Greater regulatory cooperation and transparency

• Increased confidence among Indian SMEs to pursue first-time EU filings

• Stronger EU demand for diversified and resilient pharmaceutical supply chains

The net effect is a higher volume of EU regulatory submissions from Indian manufacturers, particularly in highly regulated product categories.

Regulatory and Consulting Services Required for EU Market Entry

Indian pharmaceutical and life sciences companies entering Europe typically rely on external consulting support for:

• Selection of EU regulatory pathways (Centralised, DCP, MRP)

• CTD/eCTD dossier preparation and submission

• EU GMP gap analysis and remediation

• Clinical and bioequivalence documentation

• Pharmacovigilance system setup and QPPV support

• Medical device conformity under EU MDR and IVDR

• Post-approval lifecycle management and variations

For most Indian organizations—especially first-time EU entrants—outsourcing these functions is driven by risk mitigation, cost efficiency, and execution certainty.

Key European Markets for Indian Pharma Expansion

Although EU approvals can provide pan-European access, certain countries serve as strategic anchors:

• Germany – Europe’s largest pharmaceutical market with strong generics demand

• France – High-volume market with complex pricing and reimbursement systems

• Netherlands & Belgium – Regulatory, logistics, and distribution hubs

• Italy & Spain – Large public healthcare markets driven by tender systems

Each market introduces additional language, regulatory, and reimbursement complexity, further increasing the demand for specialized consulting expertise.

Competitive Landscape in European Pharma Consulting

The consulting ecosystem supporting Indian companies entering Europe includes:

• Global CROs and integrated life sciences consultancies

• EU-based regulatory, pharmacovigilance, and quality specialists

• Medical device and notified body experts

• India-origin consultancies with EU presence or strategic partnerships

As EU entry activity accelerates, competition is shifting away from pricing toward regulatory depth, execution quality, and local EU expertise—areas where experienced said firms differentiate.

Risks and Constraints for Indian Companies

Despite strong tailwinds, challenges remain:

• Stringent EU quality and compliance expectations

• Capacity constraints at notified bodies for medical devices

• Country-specific pricing and reimbursement hurdles

• Increased competition as EU companies gain improved access to India

These constraints reinforce the need for early regulatory strategy, realistic timelines, and expert execution.

What This Means for the Pharmaceutical Consulting Market

The India–EU trade deal is not a one-time boost—it is a structural catalyst.

Over the coming years, Europe is likely to experience:

• A sustained rise in EU filings from Indian pharma and medtech companies

• Continued growth in regulatory outsourcing and compliance services

• Expanding demand for pharmacovigilance, quality, and post-market consulting

For consulting firms operating at the intersection of Indian manufacturing strength and EU regulatory rigor, this represents a long-term, high-value growth opportunity.

Conclusion

The “Mother of All Trade Deals” between India and the European Union marks a defining moment for Indian life sciences companies seeking access to highly regulated global markets. While trade barriers may decline, regulatory expectations remain uncompromising—making pharmaceutical consulting the true enabler of EU market entry.

As more Indian companies turn toward Europe for sustainable growth, the demand for specialized, cross-border regulatory expertise will only intensify. Those who master EU regulations will be the ones who convert trade opportunity into durable market presence.

At RIAR Consulting, we believe the future belongs to organizations that combine global ambition with regulatory excellence.