Bilcare Ltd Management Discussions

Industry Outlook:

The Indian pharmaceutical industry is expected to continue its growth trajectory, driven by both domestic and international demand. The growth is driven by factors such as increased health insurance coverage, better access to healthcare facilities, and rising per capita income. The industry is also likely to play an increasingly significant role in global healthcare, particularly in the supply of affordable and accessible medicines.

The clinical trial supplies industry is poised for continued growth, driven by the increasing complexity of clinical trials, technological advancements, and a growing emphasis on diversity and inclusion. Companies are increasingly focusing on optimizing supply chains, leveraging digital technologies, and collaborating to meet the evolving demands of the industry. Market research reports predict a significant increase in market value by 2030, with a CAGR of 8.9% between 2025 and 2030.

The Clinical Trial Supplies market is expected to reach US$ 2.70 billion in 2024 to US$ 4.79 billion by 2033, with a CAGR of 6.58% from 2025 to 2033. The market is expanding faster due to a number of factors, including the rise in chronic illnesses, stricter regulations, the globalization of clinical trials, biotechnology breakthroughs, the introduction of biosimilars and orphan medications, and the use of cutting-edge technologies.

Clinical Trial industry is embracing digital transformation and exploring innovative therapies, including biotechnology and biosimilars. Technical advancements in AI for clinical trials, drug discovery, and operational efficiency are the key drivers behind the rapid expansion. The clinical trial supplies industry is experiencing substantial growth, driven by increasing R&D investments and the rising number of clinical trials.

Likewise, pharma packaging is no longer viewed solely as a protective layer—it now plays a central role in patient safety, supply chain integrity, and regulatory compliance. Features such as tamper evidence, track-and-trace serialization, anticounterfeit printing, and QR code-enabled patient information are increasingly standard. Packaging solutions are being designed to protect sensitive formulations, extend shelf life, and improve patient adherence.

Bilcare Group through its Subsidiary, with its long-standing expertise in PVC and PVDC films, continues to serve as a trusted supplier to leading domestic and global pharmaceutical companies. The companys established manufacturing base, R&D capability, and quality systems position it well to meet evolving customer needs and international compliance standards.

• Increased Number of Clinical Trials: The global clinical trial supplies market is experiencing significant growth due to the expanding number of clinical trials across various therapeutic areas, including oncology and rare diseases.

• Rising R&D Spending: Pharmaceutical and biotechnology companies are significantly increasing their research and development investments, which directly impacts the demand for clinical trial supplies.

• Globalization of Trials: As clinical trials expand geographically, the need for efficient and reliable supply chain management, including specialized logistics solutions, is increasing.

• Focus on Diversity and Inclusion: Regulatory bodies are emphasizing the need for greater diversity in clinical trials, which is prompting pharmaceutical companies to expand trials to new locations and utilize decentralized trial models.

• Advancements in Technology: Digital transformation is playing a crucial role in enhancing the clinical trial supplies industry, with technologies like blockchain, AI, and IoT improving supply chain efficiency, transparency, and compliance.

• Complexities in Supply Chain: Managing the logistics of temperature-sensitive and time-critical materials across global supply chains presents significant challenges, requiring robust solutions and specialized expertise.

• Cost Management: Balancing the escalating costs of clinical trials, particularly for large-scale and global studies, is a key consideration for sponsors.

• Phase III Trials Dominance: Phase III trials, due to their larger scale and complex logistical needs, currently account for the largest market share, according to industry reports.

• Comparator Sourcing is an expanding field within clinical trials, having doubled in size over the past three years. According to a report by the Institute for Healthcare Informatics, the innovation in cancer drugs is expected to continue growing over the next five years, with oncology currently accounting for 25% of the global late-stage pipeline. As most drug candidates are being tested against the standard of care, the demand for secure and transparent sourcing of comparator drugs and non investigational medicinal products (NIMPs) is likely to rise significantly. Sourcing optimization is increasingly being achieved through a shift from centralized to local comparator suppliers. Global sourcing companies are beginning to evaluate local market capabilities for quality certificates and actively export drugs for QP release.

• Indias pharmaceutical packaging market is estimated at USD 2.2 billion in 2024 and is projected to grow at over 8% CAGR through 2030, outpacing global packaging market growth. This is supported by export growth, specialty therapies, sustainability push, automation & precision.

• PVC and PVDC blister films remain dominant for solid oral dosage packaging due to their proven barrier protection and cost-effectiveness. However, newer laminates— combining PET, PE, and proprietary coatings—are gaining traction for sustainability and performance advantages.

• High Costs: Rising costs, especially for temperature- sensitive biologics and complex global trials, can significantly impact trial budgets.

• Regulatory Hurdles: Navigating the regulatory landscape for clinical trials across different countries can be complex and time-consuming. Compliance with safety and ethical standards is crucial, but can also add to the cost and complexity of trials.

• Geopolitical Instability: Global events, such as trade wars and political conflicts, can disrupt supply chains and increase costs. For example, the conflict in Ukraine has impacted raw material sourcing and freight costs.

This year, Bilcare focused on development, manufacturing, primary and secondary packaging with various innovative blinding techniques, IWRS, storage at variable temperatures, and global distribution through depots/ sites with capabilities to manage storage, distribution, returns, and destruction. Services related to IMPs (Investigational Medicinal Products) include:

- Comparator Procurement

- Development, Manufacturing, Primary and Secondary Packaging

- Storage at Ambient and Controlled Temperatures

- Logistics within India and globally

- Returns & Destruction

- Analytical & Regulatory

- IWRS

In response to the increasing demand in the CTMS market, Bilcare GCS has strategically aligned its resources. Key achievements for the year include supporting pharmaceutical companies, CROs during USFDA audits, supporting funded research programs by academia, attending Investigator Meetings, Clinical research conference and expanding global depot partnerships to cover most locations worldwide. These efforts position Bilcare GCS to regain market share and maximize profits by offering innovative, compliant, and efficient services to clients.

The Comparator Sourcing sector within clinical trials has grown rapidly, doubling in size over the past three years. Bilcare is becoming a formidable player in this market as global sourcing companies assess local capabilities for quality certification and actively export drugs for QP release.

Bilcare has established robust Standard Operating Procedures (SOPs) and strong internal checks and controls, ensuring best practices are followed globally. This is evidenced by the company successfully completing all major customer/client audits without any critical observations. The company plans to expand its services with its own manufacturing setup and also its own depot services globally to cater to the clinical trial industry, offering comprehensive solutions under one umbrella.

For pharmaceutical packaging, the Group is increasingly focusing on sustainable packaging innovations—developing recyclable mono-material solutions, introducing solvent-free coating processes, and optimizing barrier properties. The Group is investing in coating technologies that reduce material weight while maintaining barrier performance—reducing cost and environmental impact.

Bilcare has implemented an effective Internal Financial Control system, ensuring that all transactions are properly authorized, recorded, and reported in compliance with the companys policies and SOPs. Internal auditors independently evaluate the adequacy of these controls and report significant deviations to the Audit Committee.

Bilcare Ltd currently has only one reportable segment. During the year under review, on a standalone basis, the Company reported a profit before exceptional items and tax of 545.36 lakhs as compared to a loss of 518.01 lakhs in the previous year. The improvement is supported by a higher share of value-added business. While the performance indicates progress towards profitability, the Company continues to remain focused on strengthening its operational efficiency and financial resilience.

On a standalone basis, positive variances are evident, with improved debtor turnover ratio (3.6 times) and inventory turnover ratio (33.8 times), driven by better collections and lower inventory levels. The net profit ratio has remained almost constant due to a one-time exceptional gain in the previous year and the increase in the other income of brand royalty in the current year. Since there is no debt, related ratios are not applicable.

The company faces currency fluctuation risks, but these are naturally hedged due to exports. It also encounters credit and liquidity risks, mitigated by creditworthiness and rolling forecasts.

The Management Discussion and Analysis includes forwardlooking statements about the companys objectives, projections, estimates, and expectations. Actual outcomes may differ significantly due to factors such as changes in political and economic conditions, legal developments, litigation, labor relations, exchange rate fluctuations, and other costs.