INDIA BIOECONOMY REPORT 2020 BIOECONOMY REPORT MARCH 2020

©BIRAC

02 | IBER 2020 CONTENTS

Preface ...... 4

Executive Summary: Mapping of India’s BioEconomy ...... 6

Introduction ...... 7 sector ...... 7 BioEconomy ...... 7

Background and Methodology of BioEconomy calculations ...... 8 Theoretical overview ...... 8 Accounting data ...... 9 Standard Sectors used for BioEconomy calculations ...... 9

State of play: Importance of Biotechnology ...... 10 Overall size and structure of the Biotechnology sector ...... 10 Structure ...... 10 Indian BioEconomy in 2019 ...... 12

Recommendations ...... 14

How the world sees BioEconomy? ...... 18 Sectors included into BioEconomy strategy and monitoring in the selected countries, plus the EU ...... 19

BioEconomy definition and strategy of different nations ...... 20

Ecosystem in India ...... 22 BioTech Startups (2012-2018) ...... 22 Location of BioTech Startups in 2018 ...... 23

Policies that could further trigger India’s BioEconomy ...... 23

Acknowledgements and Sources ...... 30

03 | IBER 2020 PREFACE

The world is moving towards BioEconomy. This concept is getting increased attention from the governments and policy-makers of different countries. Countries see BioEconomy as a foundation to solve fossil fuels crisis, climate change, address food and nutrition problems, and push innovations to create a healthy world. Policy-makers are beginning to consider BioEconomy at the macro-economic level. The India BioEconomy Report 2019 is also an effort to bring the multi-pronged concept with appropriate definitions and dimensions to the forefront. The goal is to set up an appropriate Methodology to measure the national BioEconomy and monitor its performance over a period of time. The initial findings of the study suggest that India’s BioEconomy for calendar year 2019 is valued at $62.5 billion.

It may be recalled that the Department of Biotechnology (DBT) has been propelling India’s BioEconomy by providing an enabling ecosystem to promote biotechnology research and improve capacity building across the country. The focus has been on fostering cutting edge-research and innovation alongside translational research. The initiatives are aimed towards boosting innovative research, empowering people, building world class infrastructure, and supporting public-private partnerships across all sectors like , healthcare, industry and environment.

India’s National Biotechnology Development Strategy, announced in 2015, lays major emphasis on generation of biotech products, processes and technologies for enhanced efficiency, productivity and cost-effectiveness in the areas of agriculture, food and nutritional security; affordable health care and wellness; environmental safety; clean energy, , and bio-manufacturing.

Further, there is strong emphasis on skill development programmes in close coordination with State Governments. The policies announced by the Government have strengthened the institutional mechanisms for empowering innovation and ensuring scale up and . The emphasis has been on technology-driven research aimed at improving lives and living

04 | IBER 2020 of millions by providing affordable solutions to public health problems impacting the society at a large.

There has been a paradigm shift in the relationship between Government, Academia, Industry, Startups and Civil Society. The Department has made special efforts to contribute through its various programmes to the National Missions launched by Indian Prime Minister Mr Narendra Modi. Some of the prominent missions are Swasth Bharat, Swatch Bharat, Startup India, and Digital India.

The Department through its Public Sector Undertaking-BIRAC has created a vibrant ecosystem for innovation to thrive in our country as well. Innovate in India (I3) is an industry- academia collaborative mission of DBT in collaboration with World Bank for accelerating discovery research to early development of and to be implemented by Biotechnology Industry Research Assistance Council (BIRAC).The aim of the mission is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development. The program will specifically focus on the development of new vaccines, bio- therapeutics, diagnostics and medical devices to address the rising burden of diseases in the country.

Our continuous effort is to engage with all stakeholders as we move forward in our journey to make India a $100 billion BioEconomy by 2025. We understand that a holistic approach with continuous innovation is important in developing a BioEconomy that is based on the principles of affordability, accessibility, and sustainability.

DR RENU SWARUP Secretary, Department of Biotechnology,

05 | IBER 2020 EXECUTIVE SUMMARY: MAPPING OF INDIA’S BIOECONOMY

• The India BioEconomy Report (IBER) is an effort to map India’s BioEconomy and monitor the extent to which policies adapt to growth, resilience and sustainability needs.

• Efficient policies are essential to meet increasing demand for better health, fuel, and feed in a sustainable way.

• While growth in demand presents significant opportunities for application of biotechnology, government policies have a proactive role in addressing challenges such as increasing productivity growth, enhancing environmental performance and adaptation to climate change, and improving resilience of unforeseen circumstances.

• Further, Policy evaluation provides needed evidence for governments to ensure that these policies address these challenges properly.

• Policy packages are also needed to be coherent and efficient to enable the sector to develop to its full potential and achieve key public policy objectives.

06 | IBER 2020 INTRODUCTION

BIOTECHNOLOGY SECTOR on translational research. The Government of India (GOI), through the Department of Biotechnology (DBT), since Regular interaction with all stakeholders 1986, has been promoting and nurturing the of the sector from academia to industry cause of biotechnology in India. The result to consumers has led to bringing in timely of this is bestowed with a large pool policy interventions and give fillip to the of outstanding people and infrastructure, sector. innovative schemes to fund and nurture the entire ecosystem, and a system that is put in BIOECONOMY place that can nurture the future growth of BioEconomy as a concept acquired this sector. A cornerstone of India’s thinking prominence when has been to align with world trends, yet take announced BioEconomy strategy as early measures that are helpful to local conditions. as 2012. This strategy was reviewed for India embarked on the vision to become the relevancy in 2018. As per the revised a BioEconomy and to extend benefits of strategy the BioEconomy covers all sectors biotechnology to its citizens during early and systems that rely on biological resources part of last decade. One of the visions (animals, plants, micro-organisms and was to see if India can reach $100 billion derived , including organic waste), BioEconomy by 2025. The key components their functions and principles. It includes of this BioEconomy was to take all aspects and interlinks: land and marine ecosystems of the biotechnology sector like new forms and the services they provide; all primary of vaccines, novel therapeutics, production sectors that use and produce biosimilar manufacturing, stemcells, biological resources (agriculture, , systems , synthetic biology, improved and ); and all economic hybrids in agriculture, renewable energy and industrial sectors that use biological from biological sources, clean technologies, resources and processes to produce food, and . feed, bio-based products, energy and services. The European BioEconomy is BIRAC, a public sector undertaking of DBT aimed to have sustainability and circularity has established several industry focused at its heart to drive the renewal of its schemes such as SBIRI, BIPP Biotechnology industries, the modernisation of primary Ignition Grant, BioNEST, SITARE, PACE, production of systems, the protection of the SIIP, SEED, LEAP, Fund of Funds – AcE, etc. environment and . These programmes are some of the first of its kind to help the industry. This was to The Biotechnology Innovation Organization help support innovation in R&D, help build (BIO) in October 2019 submitted its capacities for future growth, and are enabling comments to the Office of Science mechanisms for better collaborations Technology and Policy (OSTP) on the between industry and academia and focus BioEconomy, explaining the critical role

07 | IBER 2020 America’s biotechnology industry plays in “Yet while our progress has been amazing, feeding, fueling, and healing the world. the continued success and leadership The comments were highlighted by Tom of the American biotech industry is not DiLenge, president of BIO’s Advocacy, Law guaranteed. We cannot abandon the policies & Public Policy Division, during The White that have made our BioEconomy the House Summit on America’s BioEconomy strongest and most dynamic in the world, as follows. and we must work to update our policies to meet the challenges posed by the next wave “It’s a remarkable time for the biotechnology of biotechnological innovations.” industry in America. Our world-class scientists, brilliant researchers, and savvy Increasingly all regions of the world entrepreneurs are making an enormous are looking at strategies to boost their difference in improving the health of our respective BioEconomies. India is one of the loved ones and our planet,” DiLenge noted. early adopters of this core philosophy.

BACKGROUND AND METHODOLOGY OF BIOECONOMY CALCULATIONS

THEORETICAL OVERVIEW and its significance in the national economy The term BioEconomy generally refers to an are monitored using the indicators provided economy using renewable natural resources by Statistics Finland. The National to produce food, energy, products and Strategy 2025 (2015) emphasises the need services. The important renewable natural to extend forest statistics to cover the entire resources include the biomass in , BioEconomy. The objective of the project soil, fields, bodies of water and the sea and entitled “Statistics of the modernized forest fresh water. sector” (2015–2018), co-ordinated by Luke, was to “develop the statistics of forest, Europe has been at the forefront of pushing energy and chemical industry interfaces, the BioEconomy and let us take the Finnish nature tourism, forestry-related services BioEconomy Strategy (2014) as a case and other forest-based businesses and to understand how the BioEconomy is ecosystem services.” calculated. The growth of the BioEconomy

08 | IBER 2020 Basically, the scope of BioEconomy ACCOUNTING DATA calculations is based on several publicly Output at basic prices consists of products available statistics. And some nations are manufactured during a calendar year. Three also focusing on obtaining statistics for categories of output are distinguished: import constituents so that they can help in market output, output for own final use, better estimates. So the transactions that and other non-market output. Non-market are recorded try to capture calculations output is excluded from the BioEconomy related to output, value additions, calculations. investments, employment, exports and imports of BioEconomy goods, etc. Value added (gross) refers to the total value generated by units engaged in Also sectors that are defined as being part of production activities. In market production, the BioEconomy have been selected in their it is calculated by deducting from the entirety for the calculations by many nations unit’s output the intermediates (goods and in their estimates. Further the relative share services). of the BioEconomy has been estimated for some sectors using expert opinions and Number of people employed includes other statistical sources including media people drawing a salary and independent reportage. entrepreneurs who participate in production activities in the national economy. The In Finland the output and value added are statistics covers all employees and no age measured at basic prices and calculated limits are defined for employed people. using both current prices and fixed prices at the previous year’s prices. Exports Investments consist of acquisitions, less are measured at purchasers’ prices and disposals, of fixed assets. Fixed assets are calculated using both current prices and tangible or intangible assets produced as fixed prices. Export volumes of outputs from production processes that are based on the product classification are used repeatedly, or continuously, in applied in Export Import statistics. processes of production for more than one year. The calculations only take into account the direct effects generated by BioEconomy STANDARD SECTORS USED FOR sectors. The indirect effects on sectors BIOECONOMY CALCULATIONS supplying e.g. machinery and equipment, The datasets take into consideration various raw materials or services as inputs to the sectors either completely or partially in the BioEconomy are deliberately excluded. BioEconomy.

The Indian BioEconomy calculations are Reliability of calculations: In interpreting also based on some of the best practices sector-specific figures many variables followed as mentioned above and below are that can affect the coverage and quality of the definitions that have been assumed. calculations are applied. Further, in many important sectors, where there are no

09 | IBER 2020 statistics or data, the relative share of that chemical or food industry is uses for arriving sectors’ contribution to BioEconomy is the figures of Bioindustrial segment. arrived at seeking estimates from experts. The data is also collated from various The statistics on BioEconomy exports publications and analysts report as well. are estimated using the Export data from Government. The most important sector-specific characteristics are also taken into account. This is a first time effort to initiate the For example, the share of renewable energy process of tracking BioEconomy every sources are used to calculate the totals of quarter in a methodical way so that it helps BioEconomy. Similarly, the textiles industry the Government to assess the Roadmap and may be input statistic for the BioEconomy steer the BioEconomy. estimate for the BioAgri market. The size of

STATE OF PLAY: IMPORTANCE OF BIOTECHNOLOGY

OVERALL SIZE AND STRUCTURE OF contributed to 58 percent share of the total THE BIOTECHNOLOGY SECTOR BioEconomy by value. Half of the BioPharma The Biotechnology industry’s economy is economy is through diagnostics and valued at $62.5 billion for calendar year 2019 medical devices. Vaccines account for 30 as against $51 billion in 2018 and $44.47 percent of the BioEconomy by value, while billion in 2017. The BioEconomy registered biotherapeutics contributed for the rest. 23 percent growth compared to the 14.68 percent growth in 2018 and 6.8 percent BioAgri is the second largest contributor to growth in 2017. the country with 19 percent share. Bt cotton generates nearly 99 percent of the value and STRUCTURE pesticides and fertilizers account for less It was a good year for India’s BioEconomy than one percent share within the sector. in 2019. The economy was boosted by the performance of the BioPharma and Research services’ contribution to BioServices sector, specifically the contract BioEconomy along with the BioIT and IT research and manufacturing services. The healthcare portfolio is estimated at $9.5 BioEconomy continues to be spearheaded billion. Most of the companies have a biotech by the BioPharma segment. It has alone R&D arm and offer contract services, while

10 | IBER 2020 INDIAN BIOTECH INDUSTRY (PROJECTIONS)

$51 Billion $62.5 Billion $85 Billion $102 Billion

2018 2019 2023 2025

INDIAN BIOECONOMY AT GLANCE

$12 Billion 1 Million 2500 + 15,500+ Biotech India’s Biotech India’s Biotech Biotech Companies Graduates Industry Revenue Workforce in India Every Year

Source: KBITS Primary Research Based Profiling of Biotech Sector in Karnataka Source: ABLE ( Association of Biotechnology Led Enterprises)

there are some dedicated CROs offering the well. The sector accounted for nearly 8 entire spectrum of CRO services including percent share. The contributions of the contract discovery, development, and even enzymes and sectors are estimated manufacturing. The sector recorded 19 at 46 and 54 percent share of the total percent growth. BioIndustrial segment respectively. The BioIndustrial segment has recorded nearly BioIndustrial segment has also performed 25 percent growth. While the enzymes

11 | IBER 2020 business generated $2.3 billion BioEconomy, identity of certain category of persons and the Biofuels accounted for $2.7 billion provides provision for establishment of a DNA BioEconomy. The total BioIndustrial sector Regulatory Board (DRB). A major Mission was valued at $5 billion. India continues program on Antimicrobial Resistance (AMR) to import large volumes of products. was launched in October, 2018 with the vision This gap in import and export presents an to develop indigenous and cost-effective immense potential that can be harnessed therapies against AMR. India has embarked in order to make India a leading producer on large multi institutional microbiome of Biotechnology and allied products and project to find out country- specific health services . solutions. The project is funded by the Department of Biotechnology (DBT) for a Here are some of the other interesting period of five years and ends in 2022. This developments in 2018 that can propel the microbiome project has identified 19 major BioEconomy further: India approved “The endogamous groups and 13 tribes. DNA Technology (Use and Application) Regulation Bill, 2018”. The Bill has been INDIAN BIOECONOMY IN 2019 formulated for the regulation of the use and The Indian BioEconomy in 2019 recorded a application of Deoxyribonucleic Acid (DNA) good growth looks like it is on the path to technology with the aim to establish the achieve $100 Billion by 2025.

INDIA’S BIOECONOMY VALUED AT $62.5 BILLION IN 2019

INDIAN BIOECONOMY SEGMENT VALUE IN $BILLION (2019) BIOAGRI 12.0 BIOINDUSTRIAL 5.0 BIOPHARMA 36 CRO/BIOIT/Research 9.8 TOTAL BIOECONOMY $62.5 B

12 | IBER 2020 BIOECONOMY - BY VALUE INDIAN BIOECONOMY SUB-SEGMENT VALUE IN $BILLION (2019) BIOAGRI 12.00 BT COTTON 11.1 BIOFERTILIZERS / BIOPESTICIDES 0.9 BIOINDUSTRIAL 5.00 ENZYME 2.30 BIOFUELS 2.70 BIOPHARMA 36.00 BIOLOGICS / THERAPEUTICS 7.00 VACCINE 12.00 DIAGNOSTICS / MEDICAL DEVICES 17.00 BIOIT/CRO/HEALTHCARE RESEARCH 9.50 TOTAL BIOECONOMY $62.50 B

BIOECONOMY – BY KEY PRODUCTS SEGMENT SUB-SEGMENT PRODUCT SHARE (2019) Diagnostics / Medical Devices 50.60% Vaccine 35.71% BT Cotton 33.04% Biologics / Therapeutics 20.83% BIOIT/CRO/Healthcare Research 15.20% Biofuels 8.04% Enzyme 6.85% Biofertilizers / Biopesticides 2.68% TOTAL BIOECONOMY $62.5 B

BIOECONOMY – BY SEGMENT SEGMENT VALUE IN $BILLION (2018) BIOAGRI 11 BIOINDUSTRIAL 4 BIOPHARMA 28 CRO/BIOIT/Research 8 TOTAL BIOECONOMY 51.00

13 | IBER 2020 RECOMMENDATIONS BioEconomy action plan suggested by Industry

The Association of Biotechnology Led • Environmentally sustainable solutions for Enterprises (ABLE) has been engaging the improving food, energy and water security in members and key stakeholders to raise India using Biotechnology will become more India’s efforts in the direction of Bio-based commercially prominent. BioEconomy. It is important that we have two important traits in the BioEconomy OUR NATIONAL VISION & GOAL: 2025 Strategy. • A $100 billion thriving BioEconomy by 2025. 1. A system to incorporate and action the suggestions and recommendations after • 10 million jobs driving the BioEconomy due deliberations and; led by products and services

2. A system to measure, monitor, analyze • Delivering affordable access to global and record the benefits of the BioEconomy healthcare through high quality, cost system. competitive Biological medicines, vaccines and diagnostics. WHERE WILL WE BE IN 2025? • In Business-as-Usual scenario, India’s • Providing access to high value medical BioEconomy to be around $80 billion by treatments in emerging areas like 2025. therapy, vein to vein therapy and stem cells therapy • But India’s BioEconomy will approach $100 billion in 2025 if various bottlenecks • Producing high tech agricultural products in regulation and policies are removed and that are high yielding & environmentally industry given stimulation sustainable

• Further, India’s BioEconomy can support • Adopting , enzyme ~ 10 million jobs in 2025 @ $100 bn revenue technologies and bio-fuels to reduce the carbon footprint and build a green future for • Over 100 “Made in India” Biotech products India. will be in global markets • An innovation engine to improve the lives • Emerging cell and gene therapies will tap of people in India and around the world. into the Indian Market to access high skilled talent and low delivery cost. This can create ABLE’S OTHER RECOMMENDATIONS a large Medical Tourism opportunity. ABLE sought feedback from the stakeholders to suggest action points to strengthen India’s

14 | IBER 2020 BioEconomy Efforts. registered biotech startups.

Here are the key suggestions for the short • 200% Weighted Tax deduction on all R&D and long-term. expenses.

• The 150% weighted Tax Deduction for • Reimbursement of foreign patent filing Research Investment should be extended to expenses. outsourced research services and not just in-house R&D work. • Reclassify and adopt 5% GST for biotech research services • More investment mechanisms for innovative biotech companies to access • Duty free import of biological materials. growth capital (Many highly useful enzymes used in key food sector and bioremediation etc attract • 5-year Tax Holiday for registered biotech 25% taxation as import duty & GST. These start-ups from TDS, GST enzymes cost is about 60% of such projects and hence unaffordable. India not benefiting • Tax exemption for investments up to Rs 10 from enzyme tech advances) crore in biotech startups. • Special incentives 200% weighted tax OTHER FINANCIAL ISSUES deduction) for technology transfer to INCENTIVES FOR STARTUPS foreign countries. (To encourage India’s • Key amendments to the Biodiversity Act innovators to access global markets for to make it more industry-friendly. their technologies and bring in forex too)

• Interest free loans for foreign technology • No capital gains for investments in transfer startups at exit or IPO up to 5X.

• Duty-free manufacturing zones for • Reduce import duties on biotech products Biomed industry & consumables. (About 45% of India’s BioEconomy is accounted for by imports and • Fast track regulatory approval for hence impacts affordability for our citizens) authorized cell & gene therapies transferred from USA, Europe and Japan • Import duties on materials and machines to be waived off for startups. (2) All materials • Loans without collateral up to Rs 10 crore and machines used in agriculture should be for SMEs to set up manufacturing facilities. brought under Nil (0%) GST

• Loans without collateral up to Rs 5 • A robust public market interface to be crores for marketing support for SMEs with favorable to innovation-led growth. India approved products. should have similar avenues like London or New York. • Allow CSR funds to be invested in

15 | IBER 2020 • Idea to Proof-of-concept (Seed Capital, • Harmonization of DCGI with ICH to enable SBIRI) Indian Dossiers to be accepted overseas.

• POC to Product/Service Platform (VC- • Regulatory guidelines CRISPR/Gene- Series A+B)* edited products in human health and agriculture. • Scale for Market Share / Diversification / M&A consolidation (Private Equity) • Accelerate new framework/regulations for approval of Agricultural Biostimulants, Policy & Regulatory Issues Bio fertilizers & Novel Biocontrol Agents. • DCGI be the sole authority to approve (Currently mainly covered by the Pesticides biosimilars/biotherapeutics for product Act) approval and market authorization. Presently, there are multiple agencies • Set up a nodal agency for trials, validation involved in the approval process: RCGM, and certification of MedTech and BioTech GEAC, DSIR, DCGI, CSDCO, NPPA etc innovation under DCGI.

• Exemption to all cultivated biodiversity • Rework Agriculture policy to give clarity from the provisions of the National on GMOs Biodiversity act. When biological species ( including microorganisms, plants and • Develop a National Agriculture Policy that animals ) are cultivated by people for promotes use of emerging technologies like economic use, such activities automatically gene-editing/CRISPR, use of biomarkers, ensures their preservation maintenance development of food alternatives or plant and protection ( as opposed to wild varieties with improved yield and quality, harvested species). Hence such species Molecular Farming should be exempted from the provisions of the BDA or classified as “Normally Traded • Amend Section 3(2) of the Biodiversity Act Commodities” under Sec 40 of Biodiversity to align the definition of foreign companies Act. For example cultivated seaweed should as per Corporate Law. be exempted whereas wild harvested seaweed should not be exempted. Also • Make other amendments in the remove restrictions on export of cultivated Biodiversity Act to remove draconian biodiversity and removed from the Restricted provisions, restriction on scientific exchange Category in Schedule 2 of export rules under of information, patent filings etc. All of these DGFT. provisions are detrimental to bio-innovation in India. Distinction between cultivated/ • Exemption to startups from Biodiversity cultured and Natural can eliminate the laws, similar to Hakims, till IP is filed ambiguity and anomaly that currently exists.

ADMINISTRATIVE & POLICY CHANGES • Government tenders should have (LONG-TERM) POLICY & REGULATORY preferential norms for indigenously ISSUES manufactured medicines, vaccines,

16 | IBER 2020 diagnostics, devices and medical equipment. sector facilities are under utilized-

• Stronger push to ensure Indian companies • Fund large population genomics studies file global IP (subsidize or reimburse patent (National Bioscience Mission proposal with fees.) PSA should trigger some of this). The new data sharing and storage policies drafted • Access to lab infrastructure in public by DBT are skewing genomics towards laboratories at nominal rates for biotech academia. Industry too should benefit. companies INFRASTRUCTURE & FUNDING • ‘Make in India’ pavilion @ all major • Create Biotechnology Industrial Estates biotech conferences & trade shows globally with the following minimum infrastructure to showcase Indian Biotech products. starting with existing DBT/Government funded incubators to promote the natural • BIRAC should facilitate manufacture of growth of startups. key equipment used in biotech research and industry under Make in India program. This • The estate should have a reliable and will reduce costs and increase availability continuous source of power @ 500 KVA / within the country. acre of land

• Incentivize foreign technology vendors to • The estate should be laid with proper manufacture their products in India under roads, storm water drains, street lights and Make in India program. developed green spaces.

• Induction of more experts in agencies like • The estate should have a reliable source FSSAI, DCGI, Ayush Ministry, Patent office of water @ 1 MLD per acre and potable water treatment plant with distribution • Lateral entry of biotech industry leaders in scientific ministries at joint secretary • The estate should have a Common Effluent level and above Treatment Plant to handle the effluent from each of the plots with a capacity of 0.7 MLD • A Vision Group for Biotechnology under per acre DBT/Niti Aayog . ( Karnataka has such groups for biotech, IT, S&T since 2003) • The estate should have good connectivity to highways, airports and railway station • Policy emphasis on emerging technologies like synthetic biology, gene therapies to • The estate should be close to training allow these areas to gain traction centers, Biotechnology Clusters, Universities, including finishing schools • Encourage funding mega Genomics dedicated to the biotechnology industry. project in the private sector because public

17 | IBER 2020 HOW THE WORLD SEES BIOECONOMY?

GLOBAL TRENDS IN BIOECONOMY which measures substantial economic According to Science Direct, about 50 growth, job creation, and household countries have newly adopted BioEconomy- income for the agricultural sector from related policy strategies in the past decade. biofuel and production. Using the same U.S. data along with worldwide The second Global Bioeconomy Summit held data from Research and Markets, BIO, the in Berlin from April 12–14, 2018, highlighted U.S. Biotechnology Innovation Organization, that this global trend toward BioEconomy calculates that the global economic value of is driven by the need to address resource the biobased economy – including industrial constraints, by advances in , biotechnology, renewable chemicals and and by shifts in consumer preferences polymers, biofuels, enzymes and biobased toward sustainability. materials is $355.28 billion. The generates 58 percent of the value, or New opportunities are arising for more than $205 billion. BioEconomy in manufacturing, bio- chemistry and agriculture, but strategies Using data from USDA, the US DOE, ABF also need to include accelerated innovations Economics, and MarketLine, BIO estimates for food security, and resource protection. the direct value of the U.S. biobased economy at $205 billion, generating 1.665 million BIOECONOMY VALUE jobs. Every direct job creates additional The U.S. Department of Agriculture (USDA) employment and economic opportunities, released a new report on the BioEconomy, so the overall impact is $505 billion and 4.63 “Indicators of the U.S. Biobased Economy”, million jobs.

18 | IBER 2020 SECTORS INCLUDED INTO BIOECONOMY STRATEGY AND MONITORING IN THE SELECTED COUNTRIES, PLUS THE EU

ARGENTINA AUSTRALIA GERMANY MALAYSIA NETHERLANDS* SOUTH USA* EU AFRICA AGRICULTURE XX X XX XX X XX XX AUTOMOTIVE AND MECHANICAL ENGINEERING CHEMISTRY (INCL. XX X XX XX XX X XX XX ) BIOFUELS/ XX X XX XX XX X XX BIOENERGY X XX XX X XX CONSTRUCTION/ XX BUILDING INDUSTRY CONSUMER GOODS XX XX X SUCH AS COSMET- ICS AND CLEANING PRODUCTS FEED XX X XX XX X XX FISHERIES XX X XX XX X XX FOOD AND XX X XX XX X XX BEVERAGE INDUSTRY FORESTRY XX X XX XX XX1 X XX XX HEALTH XX X KNOWLEDGE/ X XX XX XX X X INNOVATION X PHARMACEUTI- XX X XX XX XX X XX CALS INDUSTRY PULP AND PAPER XX XX XX X XX TEXTILES XX XX XX X XX XX

Notes: X: sector included in BioEconomy strategy, XX: included in the BioEconomy strategy and monitored or measured.

*The results for the Netherlands monitor bio-based economy (BBE) and the results for the USA refer to bio-based products industries.

Source: Elaborated on the basis of several studies; Wierny, Coremberg, Costa, Trigo, & Regunaga (2015) for Argentina; Alex Cooke, personal communication (2018) for Australia; BMBF & BMEL (2015) for Germany; Zurina Che Dir, personal communication (2018) for Malaysia; RVO (2016) for the Netherlands; Ben Durham, personal communication (2018), and DST (2013) for South Africa; USDA (2016) for the USA and EC JRC (2018) for the EU.

19 | IBER 2020 BIOECONOMY DEFINITIONS AND STRATEGIES OF DIFFERENT NATIONS SOURCE: FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

Argentina: According to the Argentine fisheries. The modern BioEconomy is based Ministry of Agroindustry (MINAGRO, 2016), on knowledge and innovation in biosciences, BioEconomy consists in the “sustainable together with other technologies such as production of goods and services through engineering, chemistry, computer science the use or transformation of biological and nanotechnologies” (Department of resources”. For a country like Argentina, Industry, 2018). with opportunities for biomass production, experiences in the management of biological Germany: The German national productions, sound industrial capacities, BioEconomy strategy defines BioEconomy services, technologies, information and as “the knowledge-based production and knowledge, BioEconomy represents an utilization of renewable resources in order important opportunity to generate economic to provide products, processes and services progress and access world markets, as in all economic sectors, within the context of well as to respond to its climate change a future-capable economic system” (BMBF commitments within the framework of & BMEL, 2015). The concept of BioEconomy international agreements (MINAGRO, 2016). encompasses all economic sectors and their associated commercial services involved in Australia: The Australian Government producing, working or processing, using or generally refers to the BioEconomy as “the trading with renewable resources. sustainable production and conversion of biomass for a range of food, health, fibre Malaysia: It defines BioEconomy as and other industrial products as well as “the sustainable production of renewable energy” (Department of Industry, 2018). biological resources and their conversion For the Australian Department of Industry, into food, feed, chemicals, energy, and Innovation and Science, the BioEconomy healthcare and wellness products via encompasses “all industries and sectors innovative and efficient technologies”. In producing, managing or otherwise making addition to biotechnology, the BioEconomy use of biological resources (including organic encompasses all industries and economic waste), such as agriculture, forestry, and sectors that produce, manage and utilise

20 | IBER 2020 biological resources. This includes renewable resources between 2018 and agriculture, forestry, fisheries, food 2023, underscoring its critical role in building production, healthcare, chemicals and a robust renewable portfolio and ensuring renewable energy. a more secure and sustainable energy system, according to the International The Netherlands: The Dutch definition Energy Agency’s latest market forecast. of BioEconomy includes every “economic activity based on vegetable or animal raw Renewables will continue their expansion in materials” (RVO, 2013). It refers to the the next five years, covering 40% of global production of biomass for food, fodder, energy consumption growth, according to materials, transport fuels and energy, from the IEA’s Renewables 2018 market analysis forestry, agriculture and aquaculture (van and forecast report. “Modern bioenergy Esch, personal communication, 2018). is the overlooked giant of the renewable energy field,” said Dr Fatih Birol, the IEA’s South Africa: According to South Africa, Executive Director. “Its share in the world’s the term BioEconomy refers to “activities total renewables consumption is about 50% that make use of bioinnovations, based on today, in other words as much as hydro, wind, biological sources, materials and processes solar and all other renewables combined.” to generate sustainable economic, social and environmental development” (PUB, The focus on bioenergy is part of the IEA’s 2014). It encompasses biotechnological analysis of “blind spots” of the energy system activities and processes that translate into – issues that are critical to the evolution of the economic outputs, particularly those with energy sector but that receive less attention industrial application. than they deserve – such as the impact of air conditioners on electricity demand, or the BIOENERGY growing impact of petrochemicals on global The International Energy Agency (IEA) oil demand. Assuming strong sustainability released a report titled, ‘Renewables 2018 measures are in force, the report identifies Market Analysis and Forecast Report,’ additional untapped potential for bioenergy in 2018. As per the IEA report Modern to “green” and diversify energy usage in the bioenergy will have the biggest growth in industry and transport sectors.

21 | IBER 2020 ECOSYSTEM IN INDIA

Start-ups Government of India have been targeting With the incorporation of a record 937 2000 biotech startups in the country by the startups in 2018, the number of biotech year 2020 and the target has been surpassed startups in the country has zoomed to 2,669 in 2019 itself. The startup count was done at the end of 2018. India witnessed a frenzied by ABLE’s Research Group, analyzing data 32% increase in biotech startup formation from the Registrar of Companies under the in 2018. The average growth rates in the ministry of Corporate Affairs. On an average, previous years in startup formation has 10,000 companies are incorporated in the been in the 20-30% range. The Make In India country every month. A biotech company Facilitation Cell at Biotechnology Industry incorporated within the last 10 years is Research Assistance Council (BIRAC) and considered as a startup by government the Department of Biotechnology (DBT) of norms to avail various fiscal incentives.

BIOTECH STARTUPS 1086 (2012-2018) OTHERS 354 NATIONAL CAPITAL REGION (DELHI, GURGAON, NOIDA) 386 MAHARASHTRA 354 & TELANGANA 140 349 TAMIL NADU KARNATAKA TOTAL:2,669

% SHARE

14.46% 40.69% Maharashtra others

13.26% 13.26% 13.08% 5.25% National Capital Andhra Karnataka Tamil Nadu Region (Delhi, Pradesh & Gurgaon, Noida) Telangana

22 | IBER 2020 LOCATION OF BIOTECH STARTUPS IN 2018 Mumbai, Delhi, Hyderabad, and Bangalore are the cities of choice of registration of startups. These four cities account for 43% share of the total registrations.

386 112 104 97 Maharashtra Uttar Pradesh National Capital Region Andhra Pradesh & (Delhi, Gurgaon, Noida) Telangana 18% 12% 11% 10%

86 50 47 Karnataka Tamil Nadu Gujarat 9% 5% 5%

17 252 Kerala Others 2% 27% TOTAL: 937 POLICIES THAT COULD FURTHER TRIGGER INDIA’S BIOECONOMY National Policy on Biofuels – 2018 The document states that the crude oil price The Union Cabinet, chaired by the Prime has been fluctuating in the world market. Minister Shri Narendra Modi, approved Such fluctuations are straining various National Policy on Biofuels – 2018 in May economies the world over, particularly last year. those of the developing countries. Road

23 | IBER 2020 transport sector accounts for 6.7% of India’s appropriate price for their produce during Gross Domestic Product (GDP). Currently, the surplus production phase. Taking this diesel alone meets an estimated 72% of into account, the Policy allows use of surplus transportation fuel demand followed by food grains for production of for petrol at 23% and balance by other fuels such blending with petrol with the approval of as CNG, LPG etc. for which the demand has National Biofuel Coordination Committee. been steadily rising. Provisional estimates have indicated that crude oil required for iv. With a thrust on Advanced Biofuels, indigenous consumption of petroleum the Policy indicates a viability gap funding products in FY 2017-18 is about 210 MMT. scheme for 2G ethanol Bio refineries of The domestic crude oil production is able to Rs.5000 crore in 6 years in addition to meet only about 17.9% of the demand, while additional tax incentives, higher purchase the rest is met from imported crude. India’s price as compared to 1G biofuels. energy security will remain vulnerable until alternative fuels to substitute/supplement v. The Policy encourages setting up of supply petro-based fuels are developed based on chain mechanisms for biodiesel production indigenously produced renewable feedstock. from non-edible oilseeds, Used Cooking Oil, To address these concerns, Government has short gestation crops. set a target to reduce the import dependency by 10 per cent by 2022.” vi. Roles and responsibilities of all the concerned Ministries/Departments with The Salient Features being: respect to biofuels has been captured in the Policy document to synergise efforts. i. The Policy categorises biofuels as “Basic Biofuels” viz. First Generation (1G) Expected Benefits: bioethanol & biodiesel and “Advanced Biofuels” - Second Generation (2G) ethanol, Reduce Import Dependency: One crore lit Municipal Solid Waste (MSW) to drop-in of E10 saves Rs.28 crore of forex at current fuels, Third Generation (3G) biofuels, bio- rates. The ethanol supply year 2017-18 is CNG etc. to enable extension of appropriate likely to see a supply of around 150 crore financial and fiscal incentives under each litres of ethanol which will result in savings category. of over Rs.4000 crore of forex. ii. The Policy expands the scope of raw Cleaner Environment: One crore lit of E-10 material for ethanol production by allowing saves around 20,000 ton of CO2 emissions. use of Sugarcane Juice, containing For the ethanol supply year 2017-18, there materials like Sugar Beet, Sweet Sorghum, will be lesser emissions of CO2 to the tune Starch containing materials like Corn, of 30 lakh ton. By reducing crop burning & Cassava, Damaged food grains like wheat, conversion of agricultural residues/wastes broken rice, Rotten Potatoes, unfit for to biofuels there will be further reduction in human consumption for ethanol production. Green House Gas emissions. iii. Farmers are at a risk of not getting Health benefits: Prolonged reuse of

24 | IBER 2020 Cooking Oil for preparing food, particularly “THE DNA TECHNOLOGY (USE AND in deep-frying is a potential health hazard APPLICATION) REGULATION BILL - and can lead to many diseases. Used 2019” Cooking Oil is a potential feedstock for In a landmark decision, the biodiesel and its use for making biodiesel passed “The DNA Technology (Use and will prevent diversion of used cooking oil in Application) Regulation Bill - 2019”. The Bill the food industry. has been formulated recognizing the need for regulation of the use and application of MSW Management: It is estimated Deoxyribonucleic Acid (DNA) technology, that, annually 62 MMT of Municipal Solid for establishing identity of missing persons, Waste gets generated in India. There are victims, offenders, under trials and unknown technologies available which can convert deceased persons. waste/plastic, MSW to drop in fuels. One ton of such waste has the potential to provide The purpose of this Bill is to expand around 20% of drop in fuels. the application of DNA-based forensic technologies to support and strengthen the Infrastructural Investment in Rural justice delivery system of the country. The Areas: It is estimated that, one 100klpd bio utility of DNA based technologies for solving refinery will require around Rs.800 crore crimes, and to identify missing persons, capital investment. At present Oil Marketing is well recognized across the world. By Companies are in the process of setting up providing for the mandatory accreditation twelve 2G bio refineries with an investment and regulation of DNA laboratories, the of around Rs.10,000 crore. Further addition Bill seeks to ensure that with the proposed of 2G bio refineries across the Country will expanded use of this technology in this spur infrastructural investment in the rural country, there is also the assurance that areas. the DNA test results are reliable, and furthermore that the data remain protected Employment Generation: One 100klpd 2G from misuse or abuse in terms of the privacy bio refinery can contribute 1200 jobs in Plant rights of our citizens. Operations, Village Level Entrepreneurs and Supply Chain Management. The key components of this Bill include: establishment of a DNA Regulatory Additional Income to Farmers: By Board; accreditation of DNA laboratories, adopting 2G technologies, agricultural undertaking DNA testing, analysing, etc.; residues/waste which otherwise are burnt by establishment of the National and Regional the farmers can be converted to ethanol and DNA Data Banks, as envisaged in the Bill, can fetch a price for these waste if a market will assist in forensic investigations. This is developed for the same. Also, farmers are will aid in scientific up-gradation and at a risk of not getting appropriate price for streamlining of the DNA testing activities in their produce during the surplus production the country with appropriate inputs from the phase. Thus conversion of surplus grains DNA Regulatory Board which would be set and agricultural biomass can help in price up for the purpose. stabilization.

25 | IBER 2020 GENETIC ENHANCEMENT OF PULSES: India, such as ‘Make-in-India’ and ‘Startup A MISSION PROGRAMME India’. DBT recognizes the necessity for Improvement of legumes is one of the priority entrepreneurship development among the areas of Department of Biotechnology youth in the country and hence has several (DBT). Department has initiated a mission pioneering initiatives. program on “Genetic Enhancement on Pulses”. NITI Aayog has directed to take After successful completion of Make-in-India necessary scientific interventions in a 1.0, the facilitation cell at BIRAC under the targeted and mission mode approach in this guidance of DBT has formulated the Make- direction. Department through this “Mission in-India Action Plan 2.0. The Make-in-India programme on Genetic Enhancement of Facilitation Cell at BIRAC is also involved in Pulses” is targeting complex biological promotion and facilitation of State’s Biotech system of pulses which has been Startup policy, Startups exposure for neglected. Programme envisages providing international and national outreach, strategy farmers with improved and productive discussions of stakeholders for inputs on varieties, disease and climate resilience. policy matters, various communication Under the programme Department has and outreach activities for disseminating funded a first network project entitled information on the initiatives of DBT and “Genetic Enhancement of Minor Pulses: BIRAC. Characterization, Evaluation, Genetic Enhancement and Generation of Genomic The formally Resources for Accelerated Utilization and launched the Startup India initiative on Improvement of Minor Pulses” with ILS, January 16, 2016. BIRAC’s endeavors to Bhubaneswar as coordinating centre. scale up the number of Startups in the Project has thirteen participating Institutions country by 4-5 folds in next 5 years. across the country. Pulses targeted under the project are Green gram (Vigna radiata, BIOTECHNOLOGY PARKS/ mung bean), Moth bean (Vigna aconitifolia), INCUBATORS Black Gram/ Urad Bean (Vigna mungo), The Department of Biotechnology and BIRAC Cow pea (Vigna unguiculata), Horse gram have established Biotechnology Parks (Macrotyloma uniflorum, Kulthi) and Rice and Incubators respectively across the Bean (Vigna umbellata). country to translate research into products and services by providing necessary MAKE-IN-INDIA, STARTUP INDIA infrastructure support. These Biotechnology Biotechnology has emerged as an integral Parks offer facilities to Scientists, and Small part of the Indian BioEconomy. Currently, and Medium sized Enterprises (SMEs) Indian biotech industry holds 3% of the for technology incubation, technology global market share and is third largest in demonstration and pilot plant studies for Asia-Pacific region. accelerated commercial development. The Department so far, has supported 9 The DBT along with BIRAC is playing a crucial Biotechnology Parks in various States. role in the implementation and delivery of These are: i) Biotech Park, Lucknow, Uttar the flagship programs of the Government of Pradesh; ii) Biotechnology Incubation

26 | IBER 2020 Centre, Hyderabad, Telangana; iii) Tidco & Technology, Government of India, has Centre For Life Sciences (TICEL) Biotech earmarked 10% of its annual budget every Park, Chennai, Tamil Nadu; iv) The Golden year for promoting and strengthening Jubilee Biotech Park For Women, Chennai, biotechnology activities in the region. Tamil Nadu; v) Biotech Park Technology Towards this the DBT has also established Incubation Centre, Guwahati, Assam; vi) a North Eastern Biotechnology Programme Biotechnology Incubation Centre, Cochin, Management Cell (NER-BPMC). Kerala; vii) Biotechnology Park, Bangalore, Karnataka; viii) Industrial Biotechnology DBT has proactively launched several Parks (IBTPs), Jammu & Kashmir; and ix) region-specific programmes through Chhattisgarh Biotech Park, Naya Raipur, the intervention of modern biology and Chhattisgarh. The Department has come biotechnology in NER. These programs up with ‘National Biotechnology Parks are towards flagship R&D programmes, Scheme’ in which it is proposed to create skilling of human resource, establishment an ecosystem to absorb the start-ups which of research and training infrastructure with have graduated from the incubators and specific network programmes targeting give them a platform for further scaling up local problems including entrepreneurship their R&D activities in collaboration with the development. state government and industry. DBT has established a network of 126 BIRAC has supported 41 bio-incubators to Biotech Hubs across NER, providing provide incubation space to Startups and necessary infrastructure in universities/ entrepreneurs along with access to high colleges/ institutions and the required end instrumentation; technical, business, training in sophisticated technologies so regulatory compliances & IP mentorship as to support and promote biotechnology and networking opportunities with investors education and research. and stakeholders. This BioNEST incubator network is spread out across India including DBT has announced a 50 crore mission tier 2 cities and expected to grow to 50 in FY aiming at conservation and cultivation 2019-20. of endangered and threatened endemic medicinal plants of North and PROMOTING BIOTECHNOLOGY IN discovery of new botanical drugs for unmet NORTH EAST REGION medical needs using the rich traditional The North East Region (NER) of India has ethno-botanical knowledge and biodiversity been identified as one of the biodiversity of these states. This mission would also hotspots of the world. Rich bioresources help to improve the availability of authentic spread across NER’s diverse ecosystems and quality botanical raw material on and nurtured by indigenous communities, sustainable basis for a boom in the phyto- provide ample opportunities for furthering . economic development of the region. In order to give focused attention for the It is expected that this mission would North Eastern Region, the Department of enable farmers and phytopharmaceutical Biotechnology (DBT), Ministry of Science industries from NE states to become global

27 | IBER 2020 leaders in production and export of some BIRAC’s BIG programme has become one quality botanical drugs DBT would be the of the largest early stage programs and nodal coordinating and implementing has supported more than 500 start-ups and department for this mission and work entrepreneurs. Many of these BIG grantees closely with Ministry of DONER and other have been able to generate and receive identified institutions. follow on funding of Rs 250 crore from both public and private agencies. BIRAC has supported 3 incubation centers in NER under its BioNEST program at NATIONAL BIOPHARMA MISSION Guwahati, Mizoram and Shilong. These The National Biopharma Mission was incubation centres are to support Biotech formally launched on June 30, 2017 and the Startups and entrepreneurs with access to legal agreement with World Bank for flexible instrumentation, technical and business financing arrangements for this Mission mentorship and expertise. Additionally, of DBT was executed on April 24, 2018. BIRAC has also announced special awards The Mission aims to make India a hub for – BIRAC-TiE WInER award for Women design and development of novel, affordable Entrepreneurs and BIG award for Startups and effective biopharmaceutical products to encourage implementation of innovative for combating public health concerns. It products and technologies in NER. would strengthen translational capability of academic researchers; empower bio- BIRAC BIO-INNOVATIONS: entrepreneurs and SMEs by decreasing PROPELLING THE BIO-ECONOMY the cost and risk during early stages of The Biotechnology Industry Research product development and also elevate the Assistance Council (BIRAC), a public innovation quotient of the industry. The sector undertaking of the Department of global experience of World Bank would Biotechnology (DBT), has made a big impact be instrumental in building sustained on entrepreneurship and innovation in the global linkages, technical assistance and country. knowledge flow between public private partners for business promotion in biotech BIRAC has been able to create a pan-India sector. presence supporting 1000+ biotech Startups and entrepreneurs, 150+ research institutes, Following capacity building activities have small and medium scale enterprises (SMEs) been initiated under the mission and large industries. These beneficiaries have filed 200+ patents creating Intellectual 2 GLP bio-analytical labs (Bangalore, EDC- Property (IP) wealth with the support of Pune); 1 CMC Facility for GMP mammalian BIRAC. Noticeably, there are 110+ products work (Dharvad); 2 GCLP labs for supporting and technologies from BIRAC supported vaccine clinical trials (Pune; Bangalore); 2 startups that have reached to the markert Facilities for Rapid prototyping; EMI-EMC thus far. BIRAC supported Product Showcase safety testing (Kanpur); Preclinical Large can also be seen online http://www.biotech- (swine) animal facility for Med Tech Devices solutions.com (Hyderabad); 4 Vaccines candidates; 6 Biosimilar candidates for advancing

28 | IBER 2020 development; 2 Translational Research partnership between the public, private, Consortia for dengue & chikungunya philanthropic and civil society sectors diseases and setting up of 5 Technology undertaken with the aim to explore new Transfer Offices are being supported. ways of working to drive vaccine innovation to address public health in alignment It is envisaged that this programme will help with the WHO blueprint for R&D .The SFC deliver 6-10 new products in the next five approval for the IndCEPI Mission has been years, create several dedicated facilities for obtained in March 2019, for implementation next-generation skills, and hundreds of jobs by BIRAC. in the process. MISSION PROGRAM ON SICKLE CELL MISSION PROGRAM “IND-CEPI” ANEMIA DBT is implementing a Mission Programme Under the Control Program for hematological “Ind-CEPI” to strengthen development disorders such as sickle cell anemia and of vaccines for the diseases of epidemic thalassemia, an MoU has been signed potential in India. This Mission Programme with the Department of Health and Family aims to implement targeted support for Welfare, Govt. of Odisha. The program rapid vaccine development and also build has been initiated in phased manner public health preparedness system for starting with Khorda, Sambalpur, Koraput emerging infectious diseases in India. This (Aspirational district) and Balasore districts will help in strategic engagement with the for starting the screening and testing of the global Coalition for Epidemic Preparedness risk population. Innovations (CEPI) –an innovative global

29 | IBER 2020 ACKNOWLEDGEMENTS AND SOURCES

This report has been done CONTRIBUTORS gathering information from Association of Biotechnology Led Enterprises (ABLE) various websources and is a not-for-profit pan-India forum that represents the public data. Indian Biotechnology Sector.

Department of Commerce, ABLE (www.ableindia.org.in, Twitter @able_ Ministry of Commerce & indiabio) has over 400 members from all across Industry, Government of India India representing all verticals of the sector like Agribiotech, Bio-pharma, Industrial biotech, Biotechnology Industry , Investment banks and Venture Capital Research Assistance firms, leading Research and Academic Institutes and Council (BIRAC), a public Law Firms and Equipment Suppliers. sector entreprise of DBT, Government of India ABLE CONTRIBUTORS TO THE REPORT Ms Kiran Mazumdar Shaw, Chairman, ABLE The Food and Agriculture Mr Shrikumar Suryanarayan, President, ABLE Organization (FAO) is a Mr G S Krishnan, Vice-President, ABLE specialized agency of the Dr Goutam Das, General Secretary, ABLE United Nations Dr Anand Anandkumar, Treasurer, ABLE Mr Narayanan Suresh, Chief Operating Officer, ABLE Bioeconomy - Research Mr Srinivas Rao Chandhan, Senior Consultant, ABLE & Innovation, European Commission

Press release of various organizations and Market Research agencies and Media Publications

30 | IBER 2020 31 | IBER 2020 FOR FURTHER INFORMATION PLEASE CONTACT: Biotechnology Industry Research Assistane Council 1st Floor, MTNL Building, 9, CGO Complex, Lodhi Road, New Delhi-110003 Phone: 011-24389600 Fax: 011-24389611 E-mail: [email protected] Website: www.birac.nic.in Twitter: @BIRAC_2012