Case Study

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Background and Context

A multinational conglomerate with global revenue north of USD 20 billion engaged Sathguru to assess and prioritize portfolio offerings to the Indian lifesciences industry and investment avenues with strategic merit for near to mid-term growth. Subsequent to a global re-organization activity, the Client had embarked on a critical planning activity to shape portfolio composition for enhanced competitiveness and steer growth strategically. Sathguru was chosen due to established level of industry depth and cross-functional experience across areas of client’s offerings to the industry.

Scope

Sathguru performed a comprehensive market opportunity assessment across the following application areas covering the breadth of biotech and pharma manufacturing (small molecule pharma, peptides, vaccines, biosimilars, novel biologics et al) in India:

  1. Biopharmaceutical R&D and manufacturing inputs
  2. Pharmaceutical packaging
  3. Cold chain solutions, logistics and tertiary packaging
  4. Personal protective equipment

Using a strategic funneling approach, we assessed overall level of evolving opportunity and derived demand in each of these application areas. Merit for expanded participation was assessed after considering competitive landscape, adjacencies and white space for growth, potential for innovation led sustained advantage andacquisition opportunities and possibility of accelerated growth. Portfolio recommendations were made for the near term as well as more strategically engineered mid-term participation in the Indian growth opportunity.

Our Approach

Given substantial breadth of opportunity analyzed and high level of uncertainty around certain areas of industry investment, extensive primary research was used to gain needed strategic inputs and more than 100 key informant interviews were conducted during the study.
A mix of qualitative and quantitative assessment methods were used to identify opportunities in all the four segments. Qualitative insights on current practices, market composition, competitor analysis, unmet needs and white space analysis was done through detailed secondary research and primary research with suppliers, end-users, industry experts and other significant stakeholders in all the segments. In addition to the above, regulatory landscape was also mapped to derive the business implications of upcoming regulations in different geographies and identify emerging business opportunities. Evolving technology landscape and global research pipeline were also analyzed to infer implications for near to mid-term portfolio decisions and evolving competitive landscape.

Quantitative analysis included high-level market sizing, estimating target and addressable market size, predicting demand volume and value over the next 5 years. As most application areas assessed derived demand from final products such as biosimilars, vaccines, peptides or small molecules, anticipated scenarios were developed for the final products and level of derived demand were inferred for prioritized products. Strategic considerations that will impact investment decisions of the biopharma industry were analyzed and opportunity and risk levers were accordingly factored in.

Project Output

Final prioritization matrix was developed as a strategic input for portfolio prioritization and investment decision making. Opportunity areas were classified based on anticipated market size, strategic merit and potential for near-term, mid-term or long-term opportunities participation for growth. In prioritized application segments, more specific way forward recommendations were also made including acquisition and strategic partnership opportunities.

The study output has served as an input for global decision making and next steps (portfolio strengthening, development and implementation of commercial strategy) is currently being undertaken in certain areas recommended as high potential for near term growth.

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Background and Scope

Our client was a pioneering US company with valuation north of US$ 7 billion and drug discovery interests ranging from cellular therapeutics to dermatology.The Client was keen to develop a phytopharmaceutical portfolio that could be advanced as prescription drugs through the USFDA’s botanical drug pathway. The Client engaged Sathguru to assess scope of the opportunity, map landscape of phytopharmaceutical drug development, evaluate potential pipeline assets and finally, make recommendations on way forward on the overall portfolio strategy and potential strategic partners.

Project Approach

Sathguru adopted a bottom-up approach to comprehensively map this emerging opportunity while actively leveraging competitive intelligence to validate findings and identify leads. Since the botanical drug /phytopharmaceutical pathway is relatively recent, we also explored nutraceutical R&D programs/assets that could be repositioned as prescription drugs.
For the bottom up approach, we performed an exhaustive and comprehensive patent search to analyze prominent trends in natural product derived therapeutic solutions and identify prominent innovators in the segment. The map of potential partners/assets was also expanded through a review of institutional annual reports and inputs from primary research with key stakeholders.
A funneling approach with multiple parameters was used to shortlist assets which met key criteria prioritized with the Client. Confidential data shared by innovators was also assessed for all shortlisted assets. All shortlisted assets were finally ranked and prioritized based on techno-commercial merit.

Study Output

As part of final recommendations, Sathguru advised the Client on overall partnership merit for each individual asset/partner identified. The study was instrumental to the Client making final way forward decision on the phytopharmaceutical portfolio strategy.

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Situation Analysis

Pneumonia is the largest leading cause of mortality amongst children under 5 years of age in India. The pneumococcal vaccine market in India is currently dominated by multinationals with global sales of $4 billion. Our client Tergene, a venture led by an R&D veteran with prior history of product development addressing this unmet need in the market sought assistance from Sathguru to traverse from ideation to a feasible business in the vaccine sector.

Scope

  1. Comprehensive hand holding including support on product strategy; early monetization of opportunities; fund raising- non-dilutive and dilutive
  2. Access to next generation delivery platform for pipeline asset and
  3. Sensitization to public health funders and procurers

Output

  1. Helped venture navigate highly volatile and risky early technology development phase
  2. Assisted progress to preclinical development in a well-funded manner in partnership with a large Indian pharmaceutical company from whom a strategic investment has been structured
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Situation Analysis

Our client, a biotech company, was keen to assess the opportunity in human vaccines and develop a market entry strategy for the segment.

Scope

Sathguru performed a comprehensive opportunity assessment for the human vaccines segment and developed a business plan for the client. Sathguru assessed attractiveness of commercial opportunity and financial viability of the segment overall as well as individual products. Additionally, Sathguru also performed a techno-commercial review to understand viability of technology access and identify innovation trends shaping the mid-term industry landscape and market opportunity.

As a Phase I effort, Sathguru performed a dip stick study assessing high-level commercial opportunity across various product opportunities (currently marketed and emerging opportunities) to identify products to be considered for near term and mid-term portfolio inclusion. Based on this high-level Phase I effort, Sathguru prioritized products to be considered for Phase II which included a comprehensive review of technology access feasibility, product level RoI assessment and development of comprehensive segment strategy, business plan and financial model.

Study Output

An actionable business plan with specific recommendations on products to be pursued, capex to be incurred, technology access possibility to be explored with a full picture on financial implications.

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Title Description

Sathguru was involved in landscaping product development capabilities and product pipelines of public and private sector entities to identify opportunities for accelerating commercialization

Situation Analysis

Our client, the Biotechnology Industry Research Assistance Council (BIRAC), was scouting for expert consulting service providers to support its effortstowards conceptualizing potential Product Development Partnership (PDP) opportunities to accelerate development of vaccines and biologics in India. Complementing BIRAC’s emphasis on vaccines and biologics, the study included an effort to identify projects with significant advancement in the public research system. We engaged with most of the leading public research entities in the DBT and CSIR network, key public funders, representative sample of private entities andsignificant philanthropic funders and PDP managers.

Scope

  1. Assessed public and private funding landscape for discovery and development.
  2. Assessedtechnologytransfer capabilities and their adoption.
  3. Benchmarked tech transfer capabilities against global frameworks and structures.
  4. Identified research groups in India (public institutions) with translatable assets that could be advanced under a Product Development Partnership(PDP) model.

Our Approach

  1. Interacted (either in-person or through telephonic conversations) with several public research institutions and private biopharmaceutical companies
  2. Focused on public research entities that are recipients of significant government funding for vaccine development; public funders that focus on vaccines and biologics, and non-government funders that are focused on driving or funding product development consortia and private companies that have significant focus on vaccines and biologics

Study Output

  1. Comprehensive view of pipeline and research groups for public investors with an intent to accelerate such research.
  2. Identification of gaps in tech transfer and strengthening.
  3. Critical Assessment of PDP models adopted in India and globally (both), and recommendations for structuring enhanced value creating consortiums.
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Title Description

Sathguru led a study to assess local manufacturing capacity, pipeline strength and specifications of products in India for certain vaccines that were under consideration by the Government for near term adoption in the national immunization program.

Situation Analysis

Our client, the Immunization Technical Support Unit, is a collaborative effort of the Ministry of Health and Family Welfare (MoHFW), Government of India, the Public Health Foundation of India (PHFI) and other partners with funding from the Bill and Melinda Gates Foundation to provide techno-managerial support for scaling up India’s Universal Immunization Program (UIP) and support implementation of India’s strategic goals for immunization. To support decision making on adoption of additional vaccines in the UIP, ITSU was keen to understand capacity in India in specific identified vaccines.

Scope

Sathguru interacted with several doctors, clinical staff, mothers and families across segments and income classes in the chosen location. Through this extensive primary research effort, Sathguru analyzed high-level findings on product need, acceptability across clinical community and end user groups, key barriers to adoption, social and risk considerations, risk mitigation possibilities, operational considerations and commercial implications.Sathguru analyzed all regulatory implications of product related and health related regulations currently applicable in India.

Our Approach

The approach included analysis of information from a combination of sources – secondary research, primary research with Indian and multinational companies and information gathered from our prior interactionwith various stakeholders.

Study Output

A report illustrating a comprehensive picture of current and emerging capacity in the identified vaccines with critical details on product specifications and qualitative insights required for use in policy making and implementation.

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Background and Scope

A market leading company in veterinary biologicals wanted to strategically expand portfolio and develop prioritized products with high potential for mid-term growth. The company engaged Sathguru to landscape technology possibilities, assess relative merit, scout for potential technology partners and in-license the technologies for six identified veterinary vaccines from global public institutions or private companies.

Our Approach

Mapping global technology and IP landscape:

To map the evolving technology landscape and potential sources of technology, Sathguru conducted a detailed review of published research articles and all Intellectual Property including granted and provisional patents around the prioritized vaccines. We comprehensively mapped evolving technologies as well as details of institutions/researchers engaged in developing these.

Assessing relative merit and consultatively determining technology strategy (where needed):
Based on technology trends identified, along with the Client’s R&D head, we assessed relative merit for their R&D investments and technology strategy. For certain vaccines, due to regulatory merit we converged on prioritizing access to legacy technology already used by globally approved products including use of same strain. For vaccines with multiple technology possibilities including options such as recombinant and immune complex /vector based vaccines, a subjective and multi-factoral approach was taken to prioritize nature of technology to be accessed. Regulatory implications and timeframe for approval, considerations around scale-up and manufacturing, commercial receptiveness and technology access possibilities were all considered for such final prioritization of technology type and technology sources to be explored.

Managing outreach to potential technology providers and entire technology licensing transaction:
Sathguru reached out to all the global research institutions through their respectiveTechnology Transfer Office and private companies identified to explore in-licensing of strains and technologies prioritized. Our extensive network with global TTOs and research institutions and historical engagement with most of them was vital in accelerating these discussions. Over a course of about 12 months, we managed all steps of the transaction to successfully conclude the intended licensing transactions. This included multiple steps of negotiation of the term sheet and licensing agreements with multiple global sources of technology each having its own preference on licensing terms and transaction modalities. Where needed, technology was pooled from multiple sources for a single vaccine.

Additional handholding partnerships or knowhow access to enhance probability of success and accelerate R&D efforts:
In addition to in-licensing vaccine strains and technology needed, we also identified partnerships that can enhance probability of technology development and accelerate the overall product development process. This includes a key handholding agreement with a prolific and celebrated researcher worldwide who has been a constant support for the company ever since.

Project Output

Sathguru in-licensed vaccine strains and related technologies for six different vaccines from various global sources (USA, Canada and Europe), shaped hand holding partnerships with recognized global researchers in the space and comprehensively supported realization of portfolio aspirations of the Client. Sathguru’s support has enabled the client to develop a robust pipeline of veterinary vaccines with technology that is globally contemporary and timeline that is aggressive and accelerated.

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Sathguru Management Consultants Pvt Ltd
Plot 54, Sagar Society, Road No.2,Banjara Hills,
Hyderabad – 500034

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