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The new era of growth has begun for the biotechnology industry in India. Crucial sectors such as pharmaceuticals, agriculture, industry, services, and information technology hold the potential to transform the Indian economy and drive the country’s growth. The biotechnology industry is recognized as one of the key drivers for India’s economy targeting $5 Trillion by 2024. India is among the top 12 destinations for biotechnology across the globe, with approximately a 3% share in the global biotechnology industry. As a result of the government’s effort and support over the years, the Indian biotechnology industry is expected to grow at a CAGR of 8.5%, which shows the potential to ensure significant economic growth and development to the citizens of the country. The Indian biotechnology industry encompasses 2,700+ Biotech start-ups and it expects to grow up to 10,000 by 2024. There are more than 2,500+ Biotech companies in India. The biotechnology industry growth is driven by extensive investment in R&D promoting new drugs and vaccines, disease-resistant crops, and enzymatic manufacturing processes along with increased R&D expenditure fosters new industry product development, which in turn boosts industry revenue.
The Indian biotechnology market is composed of five major sectors that include bio-pharmaceutical, bio-services, bio-Agriculture, bio-industrial, and bioinformatics. Each sector contributes significantly to the biotechnology industry. The Indian biotechnology industry is complexly unified such that there is constant interaction between all these segments. For instance, the production of biofertilizers is a result of output from both the bio-agriculture segment and the bio-industrial segment. Similarly, the product that Bio-IT provides is heavily dependent on the research and analysis of products generated by the other segments.
BIO-PHARMACEUTICAL SEGMENT
The bio-pharmaceutical segment consists of products that are therapeutic or preventative medicines that are derived from materials naturally present in living organisms, using recombinant DNA (rDNA) technology. Biotechnology finds potential application in the healthcare sector, owing to the increasing prevalence of chronic and infectious diseases across the globe. This results in the increasing biotechnology research and government funding for the R&D of potential medicines, devices, and diagnostic tools, for accurate diagnosis and treatment of the condition. Biotechnology is gradually considered by the pharmaceutical industry as a promising field to discover and develop products that may generate high revenues and profits. The bio-pharmaceutical segment accounted for the largest revenue share of 64% in the Indian biotechnology industry in 2016. The Indian biopharmaceutical industry encompasses more than 300 companies is growing at a 12% growth rate.
Currently, biopharmaceuticals are one of the fastest-growing biotechnology segments in India. Several pharmaceutical companies have been stepping out towards the development of personalized medicine, novel therapeutics for COVID-19, cancer, and other disorders, and accurate and reliable diagnostic tools for several conditions. This has led to the growth of the biopharma sector. The significant biopharmaceutical clusters of India are located in Haridwar, Sikkim, Hyderabad, Vishakhapatnam, Chennai, Pondicherry, Mysore, Mumbai, Ahmedabad, and Delhi NCR. Serum Institute of India (Pune), GlaxoSmithKline Pharmaceuticals (Mumbai), Sanofi India (Mumbai), Reliance Life Science (Mumbai), and Intas Pharmaceuticals, Ltd. (Ahmedabad) are the top 5 companies in the Indian biopharmaceutical industry.
A FEW OF THE KEY FINDINGS IN INDIA’S BIOPHARMACEUTICALS INDUSTRY THAT ARE SHAPING INTERNATIONAL COLLABORATIVE AND INVESTMENT STRATEGY INCLUDE:
BIO-SERVICES SEGMENT
Bio-services mainly include clinical research & contract research organization (CRO) along with custom manufacturing. Bio-services has been witnessing emerging demand owing to the increasing demand for outsourcing by pharmaceutical companies for drugs, medical devices, and diagnostic tools. In addition, contract development and manufacturing organization (CDMO) offers custom active pharmaceutical ingredient (API) manufacturing services ranging from lab-scale to multi-ton commercial production with current good manufacturing practice (cGMP) scale-up. For API, CDMO services comprise the production of steroids & highly potent APIs (HPAPIs) and cytotoxics. Lonza Group AG and AbbVie are some major CDMOs across the globe. AbbVie Contract Manufacturing is known for the development of successful small molecules and biologics. Lonza is a provider of integrated development and manufacturing service for small molecule drug substances and their intermediates. Lonza is known for its API manufacturing services.
A FEW OF THE KEY FINDINGS IN INDIA’S BIO-SERVICES INDUSTRY:
BIO-AGRICULTURE SEGMENT
Bio-agriculture is segmented into hybrid seeds, transgenic crops, biopesticides & biofertilizers that improve the yield and provide a solution to the food supply. Bio-Agriculture is the third-largest segment in the domestic biotechnology industry. The bio-agriculture industry is driven by rising food demand as a result of the continuously growing population, increasing regulatory and consumer focus on sustainable agriculture, increasing health consciousness in India, and rising demand for organic products. Modern biotechnology comprises the use of genetic engineering tools. Biotechnology offers tools to farmers that can make production more manageable and more cost-effective. For instance, some biotechnology crops can be engineered to tolerate herbicides, that supports to make weed control easier and more efficient. In addition, some crops have been engineered to be resistant to insect pests and plant diseases. This can decrease the use of synthetic pesticides and make pest control more reliable and effective. Such crop production alternatives can support to meet the increasing demand for food while safeguarding crops against disease and decreasing production costs. The sector consists primarily of firms that are either technology development seed firms, with key players including Rasi Seeds; Mahyco Monsanto biotech; Ankur Seeds; Nuziveedu Seeds, and Metahelix Life Sciences.
A FEW OF THE KEY FINDINGS IN INDIA’S BIO-AGRICULTURE INDUSTRY:
Top Innovative Techniques-
BIO-INDUSTRIAL SEGMENT
Bio-industrial predominantly involves the application of biotechnology for sustainable industrial processing and production of chemical products, materials, and fuels. Industrial biotechnology (bio-industrial) involves the use of enzymes and microorganisms to manufacture goods for several industries, which include food, plastics, chemicals, pharmaceutical and agricultural products, and energy carriers. Biotechnology has applications in several industrial areas. Enzymes and microorganisms can be used to produce food supplements including energy carriers such as biogas and bioethanol, vitamin B2, and biobased plastics including polylactic acid. Industrial biotechnology uses renewable resources including vegetable oils or sugar beet from oil palms, sunflowers, and rapeseed and carbohydrates from cereals and corn. Bio-energy in India could be derived from incinerating biomass from agricultural produce, agricultural waste, and forestry products, or from the production of biofuels using agricultural products, jatropha plantation, neem forestry, or algal resources. The majority of dedicated biotechnology companies engaged in industrial biotechnology are active in the fields of pharmaceutical production and food/feed.
A FEW OF THE KEY FINDINGS IN INDIA’S BIO-INDUSTRIAL INDUSTRY:
BIO-INFORMATICS SEGMENT
Bioinformatics is an interdisciplinary scientific field of life sciences. It involves the combination of computers, databases, and software tools, to address biological questions. Research and application of bioinformatics include the analysis of genomics data and molecular sequence; genome annotation, molecular folding, building biological networks; gene/protein prediction, and expression profiling; modeling, and design; development of databases and data management systems. In addition, it includes the development of software and analysis tools; bioinformatics education and training, bioinformatics services and workflow; and mining of biomedical literature and text. The biopharma industry is actively integrating bioinformatics tools for research purposes. These tools offer certainly more efficient and possibly more cost and time proficient solutions by assimilating them with cloud computing.
Bioinformatics has been increasingly playing a vital role in almost all phases of drug discovery and development. This is the smallest segment contributing roughly 2% of the total biotechnology revenues. Bioinformatics tools are highly potential in terms of forecasting, analysis, and interpretation of clinical and preclinical findings. Bioinformatics has applications in molecular medicine, personalized medicine, gene therapy, drug development, microbial genome applications, alternative energy sources, and more. Increasing human genome research has led to the demand for bioinformatics platforms. Modern biological research is dependent on substantial amounts of data. For instance, the human genome is coded by over three billion letters. Bioinformatics applications vary from the identification of patterns in massive data sets and sequence analysis to the study of metabolic or biological signaling networks.
A FEW OF THE KEY FINDINGS IN INDIA’S BIO-INFORMATICS INDUSTRY:
GLOBAL BIOTECHNOLOGY INDUSTRY
Biotechnology involves tools that are used to adopt and modify various biological organisms, products, processes, and systems, and develop processes that are eco-efficient and profitable, unlike conventional chemical technologies. Pre COVID-19, the global biotechnology market was estimated to be around $436.4 billion in 2019, growing at a CAGR of 6.1% during the forecast period. The market is mainly driven by increasing R&D projects in the biopharmaceutical domain and rising funding in the biotechnology industry. The biopharmaceutical companies are investing heavily in the R&D projects, attributed to advances and discoveries. From genomics to personalized medicines, all the recent advancement has created significant scope in developing unique treatment options for various chronic diseases including cancer, and other infectious diseases. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), the US biopharmaceutical companies invested an estimated $102 billion in R&D in 2018. There are around 8,000 medicines under clinical trials across the globe, owing to the robust investment and funding in R&D projects.
IMPACT OF COVID-19 ON BIOTECHNOLOGY INDUSTRY
For centuries, the pandemics or global outbreaks of infectious diseases (with no known vaccines) have been responsible for millions of fatalities. Four influenza pandemics that include (H1N1 Spanish Flu (1918), the H2N2 Asian Flu (1957), the H3N2 Hong Kong Flu (1968), and the H1N1 Swine Flu (2009) have been recorded in the past hundred years. The Spanish Flu, a pandemic of 1918, was the most severe disease responsible for 50 to 100 million fatalities. A pandemic is a global concern that can be triggered either naturally or deliberately into the population, it is important to understand the natural mutation of viruses as compared to the deliberate use of pathogens as a weapon. Biotechnology has enabled to understand the different viruses and develop solutions ranging from diagnostic assays and therapeutics to prophylactic vaccines.
The outbreak of the COVID-19 was reported in December 2019, in mainland China, within months it reached across the globe. Initially, China was the epicenter of the COVID-19 in January 2020, however, Europe was affirmed as the new epicenter in mid-March (2020), as the number of positive cases and fatalities exceeded that of China’s. Recently, in August 2020, the US has taken over all the countries, in terms of positive COVID-19 cases that soared to 6 million, and mortalities that exceeded 180,000; becoming the worst-hit economy due to the COVID-19 pandemic. The total number of global confirmed cases of COVID-19 exceeded 23 million, while the number of global mortalities exceeded 800,000 until August 2020. Such a sudden outbreak of the COVID-19 has burdened the global biopharmaceutical players to develop vaccines and effective treatment options. The continuous research in the field of infectious diseases and vaccines is fueling the demand for biotechnology such as DNA sequencing, and cell-based assay.
Further, to fight against the COVID-19 pandemic, the biotechnology market players are also supporting to rebuild the pipeline and ensure that the most promising and innovative diagnostics and therapeutics reach out to people in need during the time of this crisis. In July 2020, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund, a partnership that aims to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections – also called antimicrobial resistance or AMR. The companies have raised so far nearly $1 billion new funding to support clinical research of innovative new antibiotics, that are addressing the most resistant bacteria and life-threatening infections. Such funding to promote innovative healthcare products has significantly contributed to market growth. Owing to the rising funding and advancement in the biotechnology domain by the government and private players have developed various diagnostic and therapeutic solutions to fight against the COVID-19 pandemic.
POST COVID-19 GLOBAL BIOTECHNOLOGY MARKET SIZE AND FORECAST, 2019-2026 ($ BILLION)
1. Novel vaccines and drugs, where nanomaterials can be leveraged for direct delivery of broad-spectrum antivirals and to support targeted therapies to the lungs.
2. Highly specific, rapid, and sensitive tests to detect infection or to detect immunity (serological tests).
3. Superfine filters for face masks or blood filtering.
4. Novel surfaces or surface coatings that are resistant to viral adhesion and can inactivate the virus.
5. The improvement of tools for contact tracing.
The Outlook of Personalized Medicines Seems Optimistic in the Future
The personalized medicines are gaining focus, due to their effectiveness in treating patients suffering from rare genetic disorders. The advantage of personalized medicine is higher treatment effectiveness through customization of prevention, prediction, and treatments. The personalized medicine is gaining importance owing to the rapid increase in the incidence and prevalence rate of cancer, and other chronic disorders; quick results with fewer chances of misusing the medicines, which lead to adverse drug reactions. Awareness among patient pools also leads to an increase in recognition for personalized medicine. Various techniques are developed in personalized medicine for different therapeutic areas. The personalized medicine needs a lot of tests to be done, to confirm the disease condition, which requires different biotechnology techniques. Sophisticated techniques for handling precise amounts of samples for personalized medicine are required. A large demand for technological advancements in personalized medicine is expected in the future and biotechnology will play an imperative role in the development. Hence, the growth of personalized medicine creates significant opportunities for the biotechnology market in the future.
TOP BIOTECHNOLOGY CLUSTERS AND CITIES
With a country comprising over three million square kilometers that are grouped into 28 states across eight union territories, India has space and flexibility to develop multiple centers of industrial focus. Its biotechnology hubs stand out as geographical centers that have been fostered by strategic investments to supply the necessary infrastructure, institutional support, and workforce to sustain the country’s position as among the global biotechnology leader. The biotechnology industry in India is driven by government initiatives, like setting up of more biotech parks and encouragement to public-private partnerships (PPP). The state government initiatives over the past few years have resulted in developing Biotech industry clusters in the state of Maharashtra, Andhra Pradesh, Karnataka, Gujarat, and National Capital Region (NCR) which are major contributors for the industries revenue.
TOP BIOTECHNOLOGY CLUSTER IN INDIA
India has establishedbiotechnology parks and incubators across the country to facilitate scientistsand Micro-, Small and Medium-sized Enterprises (MSMEs) with technologydemonstration, along with pilot studies for accelerated commercial development.An increase in the number of biotech incubators can boost research and promotethe growth of startups. The Department of Biotechnology has been allocated abudget of $2,090 billion for the year 2020-2021 as compared to $1,785 billionallotted in 2019-2020. The Department of Biotechnology promotes innovativeR&D activities in the biotechnology sector and also helps to translateresearch into products and services. The Department so far has supported 9Biotechnology Parks in various States.
Ø Biotech Park Technology Incubation Centre,Guwahati, Assam
Ø Biotech Park, Lucknow, Uttar Pradesh
Ø Biotechnology Incubation Centre, Cochin, Kerala
Ø Biotechnology Incubation Centre, Hyderabad,Telangana
Ø Biotechnology Park, Bangalore, Karnataka
Ø Chhattisgarh Biotech Park, Naya Raipur,Chhattisgarh
Ø Industrial Biotechnology Parks (IBTPs), Jammu& Kashmir UT
Ø The Golden Jubilee Biotech Park For Women,Chennai, Tamil Nadu
Ø Tidco Centre For Life Sciences (TICEL) BiotechPark, Chennai, Tamil Nadu
National BiotechnologyParks Scheme
On 31st March 2020,the government has introduced a ‘National Biotechnology Parks Scheme’ aims tosupport Biotech Parks in collaboration with the State Government andIndustries. It has been observed that the States where Biotech Parks/Incubators were established are either supported by the State Government incollaboration with the Department of Biotechnology or by the Private Sector. Thecollaboration is expected to create a vibrant biotechnology sector andexperience higher economic growth. Currently, Biotech Parks are not availablein all states which are hampering the industry to grow, however, a governmentscheme to setup Biotech Park in all states will help in the development of the biotechnologysector which in turn will impact in the economy of the State.
FOREIGN DIRECT INVESTMENT
Under Budget 2020-2021, and the Foreign Direct Investment (FDI) Policy of India to drive the Indian biotechnology industry. Feasible FDI policies are creating enormous opportunities for the market as foreign investors are expanding their business in India and the flourishing Indian biotechnology industry. FDI has various benefits that can boost economic growth. These are increased employment and economic growth, human resource development, development of backward areas, an increase in exports, and improved capital flow. Major foreign investors including Bosch (Germany), Limagrain (France), Tekes (Finland), Mylan (USA), BPI France (France), GE Healthcare (USA), and Abbott Laboratories (US). Abbott Laboratories, a major biopharmaceutical company operating in the country, in January 2017, announced to make India its global hub for innovation and development (I&D). The hub will be made for pre-clinical, formulation, analytical, biostudies, regulatory, and packaging functions. The increasing R&D expenditure by the leading biopharmaceutical companies for the development and evaluation of IVD antibodies for the diagnosis of various diseases is further anticipated to drive the country’s biotechnology market growth.
BEST BIOTECHNOLOGY STARTUPS IN INDIA
The Indian biotechnology market is tremendously growing owing to the significant contribution of biotech startup companies. Major biotechnology startups aggressively contributing to the market include Biocon, Sea6 Energy, Bharat Biotech, GANIT Labs, and MedGenomes. These players are continuously performing R&D in the market. During the pandemic, Biocon and Bharat Biotech have emerged as strong players to fight against COVID-19. In June 2020, the first Covid-19 vaccine candidate, Covaxin developed by Indian-based Bharat Biotech company. Phase 1 Trial Showed India’s Covaxin is Safe and Phase 2 started in September 2020. Further, in July 2020, Biopharmaceuticals company Biocon has secured approval from the Drugs Controller General of India (DCGI) for its plaque psoriasis drug Itolizumab (ALZUMAb) for emergency use in Covid-19 patients. Such impressive performance by Indian biotechnology companies to fight against COVId-19 is creating enormous opportunities for the biotechnology industry. These start-ups are supported by funding to boost R&D across the country. For instance, in July 2020, Tata Capital will invest $30 million for a 0.85% stake in Biocon's biosimilar business Biocon Biologics, valuing the company at $3.5 billion, Biocon.