Syngene International Limited has informed the Exchange about Investor Presentation
Ref: Syn/CS/SE/IP/2025-26/Dec/06
December 17, 2025
To, The Manager, BSE Limited Corporate Relationship Department Dalal Street, Mumbai – 400 001 Scrip Code: 539268
Dear Sir/Madam,
Sub: Investor Presentation.
Syngene International Limited Biocon SEZ, Biocon Park, Plot No. 2 & 3, Bommasandra Industrial Area, IV Phase, Jigani Link Road, Bengaluru 560099, Karnataka, India. T +91 80 6891 9191 CIN: L85110KA1993PLC014937 www.syngeneintl.com
To, The Manager, National Stock Exchange of India Limited Corporate Communication Department Bandra (EAST), Mumbai – 400 051 Scrip Symbol: SYNGENE
In continuation to our earlier intimation vide reference no. Ref: Syn/CS/SE/Reg 30/2025-26/ Dec/04 dated December 11, 2025 and in accordance with Regulation 30 of the SEBI (Listing the Obligations and Disclosure Requirements) Regulations, 2015, please presentation which will be shared with the Investors and Analysts at the meeting to be held today i.e. December 17, 2025.
find enclosed
Kindly note that no additional information will be disclosed to Analysts or Investors other than the information presented earlier and already available in public domain.
The above-mentioned Investor Presentation will also be available on the website of the Company www.syngeneintl.com.
This is for your information and records.
Thanking You,
Yours faithfully,
For SYNGENE INTERNATIONAL LIMITED
Phase,
___________________ Chethan Yogesh Company Secretary & Compliance Officer
Enclosed: Investor Presentation.
B o m m a s a n d r a I n d u s t r i a l A r e a , I V
B o m m a s a n d r a I n
Webinar on Clinical Trials Market - By Dr. Mrinal Kammili
17 Dec 2025
Safe Harbor Statement
Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such forward-looking statements.
Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, business outlook of our clientele and their research and development efforts, our ability to successfully implement our strategy, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition, changes in political conditions in India and changes in the foreign exchange control regulations in India.
Neither the Company, nor its directors and any of the affiliates have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition.
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Agenda
Sr. no
Timing
Particulars
1:30 - 1:40 PM
Why this webinar
Introduction to our inhouse expert - Dr. Mrinal Kammili
1:40 PM - 2:20 PM
• Clinical Trials Industry
• Overview of Syngene’s Translation and Clinical Research (T&CR) business
Led by
Nandini Agarwal
Dr. Mrinal Kammili
1
2
3
2:20 PM - 2:30 PM
• Q&A
Dr. Mrinal Kammili
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Why this webinar
•
In Q2 FY26, Syngene announced a deal for first global phase III clinical trial from a U.S.-based biotech company.
•
The trial will recruit patients across clinical sites in India and the U.S., reflecting Syngene’s growing capabilities in the global clinical trials market
• We got many questions around understanding / further clarity
of Translation and Clinical Research business (T&CR), operating models, industry and Syngene business in the segment
•
This webinar is focused on providing more on the Clinical Trials research business, industry and Syngene offerings in the T&CR segment
Please refrain from asking any questions around specific Syngene financials
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Our in-house expert for the webinar – Dr. Mrinal Kammili
• Joined Syngene in January 2025 – part of the Syngene Executive Committee
• Head of Translational & Clinical Research with over 27 years of experience in
clinical research
• A medical doctor and AHA-certified intensivist
• Previously worked as Executive Director, Board Member, and Global Head of
Business Development in Lambda Therapeutics
• Served on the Board of Novum Pharmaceutical Research Services, Lambda’s
U.S.-based subsidiary.
• Led various global operations, M&A, corporate strategy, and digital initiatives
Dr. Mrinal Kammili Head, Translational & Clinical Research
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Clinical Trials Market
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Translational and Clinical Research forms a large and growing segment within the overall global CRDMO market
Global CRDMO market expected to grow at ~9% CAGR
Key growth drivers of Clinical CRO market
Overall CRDMO Market Size (USD Bn)
330
370
320
270
220
170
120
213
2024F
2025F
2026F
2027F
2028F
2029F
Market Segment (USD Bn)
Pre-Clinical CRO1
Clinical CRO
Overall CDMO2
50
Scale adjusted
10% CAGR
41
26
0
0
11% CAGR
99
59
8% CAGR 190
129
200
100
2024
2029
2024
2029
2024
2029
Clinical CROs market forms ~30% of overall CRDMO market and growing at double digit
Source : Evaluate Pharma, Frost & Sullivan, IMAP (pharma sector update) 1. Includes Discovery and Pre-Clinical 2. Includes both Large molecule and Small molecule CDMO
1
2
3
4
5
Increasing R&D Pipeline: growing at ~7% CAGR; new drugs require clinical trials for regulatory approvals
Outsourcing Acceleration: Big pharma increasingly outsourcing R&D, Clinical trials and manufacturing for cost control, speed, and expertise.
Patient Diversity & Recruitment Pressure : Rising demand for multi- ethnic, multi-regional trials to meet regulatory and scientific requirements, driving broader recruitment strategies
Rise of virtual biotech companies with limited infrastructure and predominant reliance on CROs for integrated solutions
Cost Advantage : lower costs vs. Western markets and large pools of treatment-naïve patients make outsourcing to APAC attractive
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Market Outlook – Rapid growth in APAC and India market driven by strong tail winds
APAC leads growth; North America still dominates with ~30% of the global clinical CRO market
Level of attractiveness - Indian CRO market
North America remains the largest market
APAC & emerging markets increasing share, especially in early phase and patient-diverse studies
5-yr CAGR
13%
9%
18%
6%
11%
LATAM & Carribean
MEA
APAC
Europe
North America
2024
2029
Factor
Level of attractiveness
Future impact
LOW
High
Patient Pool
Study Timeline
Facilities & Infra
Reg. Environment
Quality of Data
Cost
India
US
Australia
Indian Clinical CRO market1 – Exceeds global growth rate
Indian clinical CRO market – Factors driving growth
($Bn)
16% CAGR
3.4
1.9
2024
2028
India’s clinical CRO market is projected to grow at 16% CAGR (2024 – 28), outpacing the global rate of 11% and In-line with APAC’s 18% growth rate
• Large Population & high disease burden – Access to Large & diverse subject pool
• Availability of skilled workforce, the count of clinical trial investigators has doubled from
2015 to 2022
• Reliable regulatory environment –New Drugs and Clinical Trials Rules (2019) – to fast-
track accessibility of new drugs, foster clinical research in India
• Supportive geopolitical dynamics – China+1, US bio secure act
•
India Provides significant cost advantage - ~40% to 60% compared to North America & Europe
Source: Frost & Sullivan, Industry reports 1 Includes BA/BE studies 2029 estimates for Indian Clinical CRO Market is unavailable
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Indian market is fragmented and players with differentiated capabilities and strong regulatory data management experience have an edge
Global Clinical CRO players
Key Success Factors
Key players in Indian Clinical CRO space
The Indian market is relatively fragmented in comparison to the global Caribbean clinical CRO industry which has large players
Key success factors for Indian players include:
• Understanding of local market and regulations: Increased drug
development complexities and heterogenous regulatory compliance for different markets
• Full-service offerings: Sponsors are increasingly seeking a
comprehensive solution for all their drug development requirements.
• Access to large patient population and track record of delivering studies within the cost, timelines and global compliance standards
•
Investments in new modalities: Emerging modalities such as biologics/ADC require deeper translational insights—multi-omics data, mechanistic biomarkers, advanced bioanalytical platforms
• Use and data and analytics: advanced digital platforms, data analytics, and AI-driven trial management, ensuring efficiency, precision, and data integrity at every stage
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Translational and Clinical Research forms an integral part of the overall drug discovery and development value chain
Discovery
Development
Commercialization
Target Identification
Lead Generation
Target Validation
Lead Optimization
Pre-Clinical
A
B
Translational Research
C
D
Animal
Phase I
Phase II
Phase III
NDA Filing
Lead Selection
Product Launch
Drug Substance & Product Development (Clinical, Stability, Scale-up)
Commercial Manufacture
Marketing / Phase IV
A
B
C
D
Translational Research
Phase I / First-in-Human (FIH) First reality check in humans
Phase II Proof of concept or failure
Phase III Execution at scale
• Turning scientific discoveries into
real health benefits
• Connects “Lab to clinic” or “bed to bedside “ by generating data that improves predictability and reduces uncertainty in drug development
• Conducted mostly in healthy volunteers; assess Safety and tolerability, PK/PD, dose escalation
• Conducted in patients with the target disease or condition
• Assesses preliminary efficacy
• Large, controlled clinical studies conducted in broader patient populations
while continuing to evaluate safety
• Designed to confirm efficacy and
• High attrition due to unexpected
human response
• Used to explore dose response, treatment regimen, and clinical endpoints
further characterize safety
• Data generated supports
regulatory submission and labelling
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Translational Science: anticipate uncertainty and de-risk before programme reaches the clinic
Basic Research
Preclinical Discovery
Translational Development
Clinical Trial
Past View
Today
Translational science was seen as a handoff point Translating preclinical data into clinical hypotheses.
It’s the foundation for planning, resourcing, and executing drug development from the earliest stages
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Pillars of translational sciences at Syngene
Pillars of translational sciences
Biobanking
Clinical biomarkers
Translational Models (Organoids)
AI-driven precision medicine
Platform development
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Patient based Clinical Trial
Clinical Study Report Writing
Protocol Development, Regulatory Dossier development, Submission & follow up (IND/SEC meetings)
Biometrics & Clinical Data Management
Clinical Trial
Trial management and Study Monitoring
Central Lab services
Clinical Supplies Management
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Syngene’s T&CR business
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Syngene’s T&CR business is now a segment within our Research business
What does T&CR business include
Syngene Strengths
Human Pharmacology Unit – Healthy volunteer early-phase BA/BE studies, drug-drug interaction studies, food effect studies, phase I studies (biosimilars, vaccines) 190 bed unit; 12 bed ICU
Track Record and Expertise: Completed 800 BA/BE studies for submissions in regulated markets. Extensive experience in managing global clinical trials across geographies with Regulatory & operational excellence
Clinical Trial Services: Patient-based clinical trials across therapeutic areas and phases.
Bioanalytical services – Supporting safety and efficacy endpoint observations and Immunoassays for PK, PD, Immunogenicity and Biomarkers.
Central Lab Services – Safety analysis in healthy volunteer and patient-based clinical trials, biomarker analysis, global sample logistics with kit building.
Allied Services like Clinical Data Management, Biostatistics, Medical Writing and Regulatory Affairs
Integrated Continuum: Continuity across the value chain from early discovery and DMPK to toxicology, biomarkers, clinical development to reduce development friction and enables confident transition from bench to bedside
Global Clinical Network: Partnerships with 180+ sites in India and leading CROs in the U.S., U.K., Jordan, Europe, Australia, Srilanka and New Zealand for early and late phase trials worldwide
Diversified Platform: Comprehensive offerings to take molecules from discovery to commercialization supported by investments in new modalities and use of digital/AI for better efficiency
State-of the-art infrastructure, FDA and EMA audited clinics and bioanalytical labs, and CAP accredited Central Laboratory.
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T&CR: Part of our diversified platform encompassing Research Services, LM CDMO and SM CDMO
Research Services (CRO)
Discovery Services
Dedicated R&D Centers
T&CR
Large Molecule CDMO
Small Molecule CDMO
Flexible Platform with capability across multiple modalities including small molecule, large molecule, peptides, oligonucleotides, antibody drug conjugates, PROTACs
SynVent - proprietary platform for Integrated Drug Discovery
SARchitect- proprietary platform for data visualization and analysis. Enables collaboration between scientific experts across geographies
Ring-fenced infrastructure for exclusive operations for an individual client
Dedicated multi-disciplinary team of scientists
Access to entire Syngene ecosystem for specialist research and development operations
Comprehensive research services through trials conducted on both healthy volunteers and patients
• Human Pharmacology Unit (Phase
I/BE studies)
• Clinical Trial Services – full solution provider for conducting global trials
• Translational services- a continuum
from preclinical to clinical trials
• Regulated bioanalysis for large and
small molecules
• Central Laboratory
Process development
Manufacturing of large molecules for clinical/commercial supplies
Associated services to demonstrate the safety, tolerability and efficacy of the selected drug candidate
cGMP-compliant facilities
State-of-the art Biologics manufacturing facilities with international presence
Drug substance and drug product development
Associated services to demonstrate the safety, tolerability and efficacy of the selected drug candidate
cGMP-compliant manufacturing of clinical supplies, and registration batches for small molecules
Manufacturing of small molecules for commercial supplies
State-of-the art API manufacturing facility
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Operating models in T&CR
2 way Model
3 way Model
Direct Syngene-client engagement
Syngene + Client + Partner collaboration for global reach
End-to-end clinical trial solutions
Shared responsibilities for large scale multi region trials with diverse population subsets
The revenue is milestone based with contracts typically spanning 15 to 24 months
The revenue is milestone based, with contracts spanning longer timeframes depending on trial design
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Strategic focus for the T&CR business
Support more complex and new modalities clinical trials
3S formula – strengthen, stabilize and streamline the existing functions and portfolio in near term
Forward integration into subsequent phases of clinical trials in mid to long term
Accelerated Decisions, Reduced Risk: Seamless integration of bioanalysis, translational science, and clinical development drives faster decisions and reduce risk
Comprehensive clinical partner: From biomarker driven early phase insights to global late phase regulated bioanalysis and clinical execution.
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Summary
T&CR part of Research Services
Big and growing market
• T&CR enables better support decisions across the drug development lifecycle, connecting discovery sciences and
clinical services
• Foundation for planning, resourcing, and executing drug development from the earliest stages
• Clinical Trials forms a large and growing segment within the overall global CRDMO market (~$60 bn global market;
growing at 11% CAGR)
Right to win opportunity for Indian players
• APAC is fastest growing market with increasing share, especially in early phase and patient-diverse studies
• India market also witnessing strong growth driven by availability of treatment naïve patient pools, cost benefits,
change in regulatory regime, supportive geopolitical dynamics
Syngene differentiation
• Extensive experience in BA/BE studies; integrated platform; experience in managing global clinical trials; regulatory
and operational excellence; adherence to global compliance standards
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Q&A
• Q&A focused on T&CR industry, business/operating model, better
understanding of Syngene offerings in the segment
• We will not be to disclose any Syngene specific financials at this point of time
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